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COPYRIGHT 2005 Health Law Institute
Introduction (1)
In early 2004, Carol Smith and David Jones (as we will call them) were seriously ill patients in Intensive Care Units at the Foothills Medical Centre in Calgary. (2) On March 4, 2004, Carol, who was 83, died suddenly and unexpectedly. (3) Just prior to her death, Carol was alert, oriented and did not seem to be in imminent danger. (4) In these circumstances, it might have been easy to dismiss Carol's death as a result of complications from her serious underlying condition. However, an astute ICU physician investigated further and ultimately it was discovered that her death was the result of receiving potassium chloride instead of sodium chloride in her dialysate solution. (5)
As a result of this adverse event, a broader investigation was commenced and the 30 bags of improperly mixed solution were immediately taken out of use. (6) This quick decisive action undoubtedly prevented the deaths of other patients. However, when patient care and pharmacy records were examined, it became clear that another patient had also died as a result of the improperly mixed solution. (7) David Jones had also been a patient in the ICU at Foothills Medical Centre and had died unexpectedly a week before Carol. (8) If Carol had not died and had her physician not been astute and diligent enough to investigate her death further, it is possible that David's death would never have been properly explained and his family would never have known what occurred.
Soon after discovering the tragic error, the health providers disclosed the error to the victims' families. In addition, after an internal investigation and consulting with the families of the victims, the Calgary Health Region (CHR) publicly disclosed the facts and accepted responsibility for the deaths. (9) This decision to publicly accept responsibility, although not unprecedented, is extremely rare. (10)
After its own internal critical incident review, the CHR instituted a number of changes aimed at avoiding similar errors in the future. (11) In addition, the CHR also launched an external independent review of the incident and its broader patient safety culture and initiatives. This review culminated in a detailed report that was released June 29, 2004. (12) The report, while generally applauding the patient safety efforts of the CHR, made 66 recommendations regarding the specific incident and the broader patient safety issues facing the CHR. (13)
There are a number of extraordinary aspects of this tragic incident. While there is no doubt that a tragic preventable error occurred and that the system failed the victims and their families, the subsequent actions of the CHR in dealing with the adverse event have been impressive. On the one hand, this incident is an example of how vulnerable our systems still are to human error and highlights the need to be ever vigilant in our patient safety efforts. On the other hand, this incident is also an example of an appropriate and proactive response to error through the prompt disclosure of the error to the victims' families and the public acceptance of responsibility. In its response, the CHR did not focus primarily on damage control, but instead focused on the victims' families and learning from the error. In addition, the decision to launch an external review and publicly share its findings is an important positive step. Moreover, the Health Quality Council of Alberta and the Canadian Patient Safety Institute have been involved in various aspects of the process and will assist with spreading the lessons learned from these tragic deaths across the province and the country.
Unfortunately, proactive responses like those taken by the CHR in this situation are still the exception rather than the rule when health providers respond to medical error. In addition, while the conduct of the CHR was laudable, it should be noted that it is much easier to proactively disclose error and accept responsibility in circumstances of clear medication errors, than when dealing with other forms of error. In many circumstances of suspected error, it would be inappropriate to take action too early, as it will often not be clear whether an error even occurred, let alone what the cause of the error was. However, at the very least, the above response by the CHR should serve as an example for how health providers should respond to adverse events that result from clear error.
While patient safety and medical error have long been a concern of the health professions, it was not until the 1999 release of the To Err is Human report of the U.S. Institute of Medicine (IOM) that the issue received widespread public and political attention. (14) Since the release of the IOM report, patient safety has been vaulted into the spotlight and is now central to reform efforts by members of the health professions, hospital administrators and governmental health agencies. All over North America, tremendous pressure is being brought to bear on all aspects of the health-care system to improve patient safety and reduce medical error.
Given the natural fallibility of humankind, the increasing complexity of our human systems and the potential for disastrous consequences if our systems fail (or we fail our systems), serious efforts must be made to reduce the incidence and cost of human error in medicine. In this paper, the unhappy relationship between health providers and the law in the context of disclosure of medical error will be discussed and analyzed. (15) In particular, the ethical and legal implications of the disclosure of medical error will be examined. In addition, some areas of potential reform of the legal system and health system will also be briefly discussed.
It is important to note at the outset that when referring to disclosure of medical error, this paper is restricted to the issues involved in disclosing errors to patients and their families. While disclosing medical errors to mandatory or voluntary government or other reporting systems raises several interesting concerns, these issues are beyond the scope of this paper. (16)
Patient Safety and Incidence of Medical Error (17)
While a detailed discussion of all of the facets of medical error and patient safety are also beyond the scope of this paper, it is important to understand the true nature of the problem before embarking on an examination of the ethical and legal implications of disclosing medical error.
The first major study of medical adverse events in the U.S. was conducted in California in the early 1970's and concluded that adverse events occurred in 4.6% of all admissions. (18) However, it was not until the Harvard Medical Practice Study was conducted in 1991 that medical error began to receive widespread attention in the medical community. (19) This study was a retrospective analysis of over 30,000 randomly selected medical charts for patients discharged from 51 New York State hospitals in 1984. (20) The Harvard Study reported a disturbingly high incidence of adverse events and concluded that adverse events occurred in 3.7% of hospitalizations (21) and that 58% of these adverse events were preventable. (22) Approximately 29% of the adverse events, when viewed by a medical-legal expert were deemed to be negligent. (23) Although most of these adverse events gave rise to disability lasting less than six months, 13.6% resulted in death and 2.6% caused permanently disabling injuries. (24)
In addition, a detailed retrospective chart analysis and review of 15,000 randomly selected admissions to Colorado and Utah hospitals during 1992 was conducted and released in 1999. (25) The Colorado and Utah Study found that adverse events occurred in 3% of hospitalizations in each state; 54% of these were preventable and 5.6% resulted in death. (26) The Colorado and Utah Study also found that 15% of surgical adverse events resulted in permanent disability or death and that 12.2% of all hospital deaths in 1992 in the two states were as a result of surgical adverse events. (27)
If the results of the Colorado and Utah Study are extrapolated and applied to the total hospital admissions in the United States in 1997, it would imply that at least 44,000 Americans die in hospitals each year as a result of preventable medical errors. (28) If the results of the Harvard Medical Practice study are similarly extrapolated, the number of deaths due to preventable medical error each year in the U.S. may be as high as 98,000. (29) By way of comparison, even based on the lower extrapolated number, the number of deaths attributable to medical error is greater than the eighth leading cause of death in the United States (30) and is roughly equivalent to a large commercial airliner crashing every second day.
In Canada, a relatively small study of adverse events in hospitals in Ontario was released in 1999. (31) However, the first and only national Canadian adverse events study was released in May 2004. (32) The methods used by the Canadian researchers in the national study were based on the protocol developed by the Harvard Study. The Canadian researchers randomly selected four acute care hospitals in each of five provinces. In total, the Canadian Study reviewed 3745 charts and concluded that an adverse event occurred in 7.5% of hospital admissions in Canada. (33) Of the 255 patients who experienced one or more adverse events, 106 (41.6%) were judged to have adverse events that were highly preventable. (34) With respect to the consequences of adverse events, the Canadian Study concluded that most (64.4%) of the adverse events resulted in no physical impairment or disability or in a minimal to moderate impairment. (35) However, the Canadian Study also concluded that 5.2% of the adverse events resulted in permanent disability and 15.9% resulted in death. (36) By extrapolation, the researchers concluded that in 2000 between 9,250 and 23,750 deaths due to adverse events could have been prevented. (37)
In addition to the adverse event studies conducted in the U.S. and Canada, adverse event studies have been conducted in the United Kingdom (38), Australia (39), New Zealand (40) and Denmark (41). While there are interesting differences in the rates of adverse events among the various studies, all conclude that injury due to medical error is a serious problem.
Ethical Duty to Disclose
The ethical imperative "first do no harm" has been a foundational aspect of the medical profession since Hippocratic times. Nonmaleficence, the contemporary articulation of the ethical obligation to avoid causing harm, is not restricted to deliberate harm. (42) Harm committed with the intent of healing is no less prohibited by the principle of nonmaleficence than malicious harm. (43) Harm from errors, system flaws, complications, accidents and known risks must all be avoided to the fullest extent possible.
However, the ethical imperative of nonmaleficence, which applies to all physicians, provides only half of the ethical answer in cases of medical error. What this principle does not deal with is what a physician must ethically do when harm is done to a patient. Since the dawn of the modern physician-patient relationship, it is difficult to see how a compelling argument could be made that doctors do not have an ethical duty to disclose errors to their patients. Doctors have long held a privileged position in society and are placed in a special position of trust vis-a-vis their patients. Physicians also hold a special expertise which is well beyond the layperson's understanding. Without disclosure by the physician or another health professional, many, perhaps most, medical errors would remain undiscovered by the patient. It is all too easy for patients to assume that adverse outcomes are simply an unfortunate result of their underlying disease or a natural risk of the treatment they received. Moreover, physicians are in a special position to either tacitly or expressly encourage these erroneous assumptions.
Surprisingly, within the medical profession, the scope of the duty to disclose medical error remains controversial and adherence to that duty is by no means universal. However, ethicists clearly endorse the full disclosure of medical error to patients. (44) It is also clear from several studies that patients overwhelmingly want to be told explicitly when a medical error has occurred and wish to be provided with detailed information regarding the nature of the error, why it happened and how recurrences will be prevented. (45) Nevertheless, it appears from the available evidence that full disclosure of medical error may be uncommon. (46) For example, in the Wu et al. study, 76% of the physicians interviewed said they had not disclosed a serious error to a patient. (47) In another study, higher incidence of disclosure was found, yet 22% of the physicians surveyed said that they would not disclose an error that led to the patient's death. (48) Perhaps not surprisingly, the researchers also found that the likelihood of disclosure decreased as the severity of the harm to the patient increased. (49)
The most well documented, and likely the most important reason for this hesitancy to disclose medical error, is the concern of the medical profession about litigation. (50) Less important and less convincing reasons for this lack of disclosure are concerns over the extent of the information that individual patients and their families would actually want, and whether or not full disclosure of the error could do harm to the patient or their family. (51) Of course, in situations where further health care is required as a result of the error, any persuasiveness that these justifications may have had disappears. Clearly, in these situations, patients must be given full information about the medical error in order to make informed follow-up treatment decisions. Without this information, it is highly questionable whether the patient's consent to the further treatment could be considered informed. If not, the consent would be vitiated and the health care providers could be liable in negligence and/or battery.
In a recent article, Thomas H. Gallagher reviews some of the ethical issues surrounding the disclosure of medical error and argues that a consensus regarding the minimum standard for error disclosure does not yet exist. (52) While Gallagher seems to accept that there is an ethical duty to disclose medical error, he argues that a minimum standard for error disclosure "seems artificial". (53) Gallagher's apparent justification for arguing against a minimum standard for error disclosure is that there is a lack of consensus about the scope of disclosure and the variable nature of the desire of patients to receive health information. (54) With respect, both justifications seem highly questionable. It is not necessary for a clear and unequivocal consensus about the exact scope of disclosure to exist before an ethical duty to disclose arises. Moreover, it is important to note that Gallagher's article was published some four months after the Council on Ethical and Judicial Affairs of the American Medical Association issued a report outlining physicians' ethical responsibilities to prevent harm and disclose medical error. (55) From the nature and tone of this report, it appears that, at least as of December 2003, the Council on Ethical and Judicial Affairs felt that there was sufficient consensus to warrant an amendment to the AMA Code of Medical Ethics. In addition, to use the fact that some patients may wish more disclosure...
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