Medical Ethics - Stanford Law School

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CHEST
Medical Ethics
Disclosing Harmful Medical Errors to
Patients
Tackling Three Tough Cases
Thomas H. Gallagher, MD; Sigall K. Bell, MD; Kelly M. Smith, PhD;
Michelle M. Mello, JD, PhD; and Timothy B. McDonald, MD, JD
A gap exists between recommendations to disclose errors to patients and current practice. This
gap may reflect important, yet unanswered questions about implementing disclosure principles.
We explore some of these unanswered questions by presenting three real cases that pose
challenging disclosure dilemmas. The first case involves a pancreas transplant that failed due to
the pancreas graft being discarded, an error that was not disclosed partly because the family did
not ask clarifying questions. Relying on patient or family questions to determine the content of
disclosure is problematic. We propose a standard of materiality that can help clinicians to decide
what information to disclose. The second case involves a fatal diagnostic error that the patient’s
widower was unaware had happened. The error was not disclosed out of concern that disclosure
would cause the widower more harm than good. This case highlights how institutions can
overlook patients’ and families’ needs following errors and emphasizes that benevolent deception
has little role in disclosure. Institutions should consider whether involving neutral third parties
could make disclosures more patient centered. The third case presents an intraoperative cardiac
arrest due to a large air embolism where uncertainty around the clinical event was high and
complicated the disclosure. Uncertainty is common to many medical errors but should not deter
open conversations with patients and families about what is and is not known about the event.
Continued discussion within the medical profession about applying disclosure principles to
real-world cases can help to better meet patients’ and families’ needs following medical errors.
(CHEST 2009; 136:897–903)
Editor’s note: The review addresses the 10th topic
in the core curriculum of the ongoing Medical Ethics
series. —Constantine A. Manthous, MD, FCCP,
Section Editor, Medical Ethics
growing number of articles in the literature
A explores
the issue of disclosing harmful medical
1–13
errors to patients, emphasizing the importance of full
disclosure and documenting the gap between this
principle and current practice. One potential explanation for this gap is that health-care workers and institutions recognize that disclosure is “the right thing to
do” but lack the moral courage to do what needs to
be done.14,15 An alternative explanation for this
disclosure gap is that important challenges and complexities make it difficult for health-care workers to
turn the general principle of disclosure into practice,
obstacles that the existing literature16 –19 has not yet
fully addressed.
The legal profession has long recognized that
“hard cases make bad law”; in other words, deriving
general principles from extraordinary cases can lead
to rules that do not work well for more common
dilemmas. Yet, analyzing difficult cases can reveal
areas where the current thinking on disclosure may
be underdeveloped and highlight the tradeoffs contained in seemingly straightforward disclosure cases.
In that spirit, we discuss three actual cases that
present challenging disclosure dilemmas. The cases
were collected from three health-care institutions in
geographically diverse areas. Although details of the
cases have been altered to maintain the anonymity
of the patients, providers, and institutions, the
essential aspects and resolutions of the cases have
been preserved.
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CHEST / 136 / 3 / SEPTEMBER, 2009
897
Case 1: Don’t Ask-Don’t Tell
A middle-aged man was about to undergo a simultaneous
kidney-pancreas transplant. As anesthesia was induced, the surgeon prepared the kidney and pancreas grafts for transplantation
on the back table of the operating room by discarding fat, fascia,
and accessory tissue. The surgeon implanted the kidney graft
without difficulty, and the implanted kidney began producing
urine. When the surgeon turned to retrieve the pancreas graft,
he realized it was no longer on the back table. An extensive
search for the pancreas graft ensued, including looking through
the trash, but it could not be located. At this point, one of the
operating room technicians realized that he had mistaken the
pancreas graft for discarded debris on the back table and had
disposed of it. He alerted the surgeon to what had happened. The
operation was completed, and the patient returned to the
recovery room in good condition.
After consultation with risk management, the surgeon decided
to tell the patient’s family that there was “good news and bad
news” in that the kidney transplant had gone smoothly and the
kidney was already producing urine but that the pancreas graft
was “not transplantable,” so a second operation to implant a
different pancreas graft would be required. If the patient’s family
inquired about why the pancreas graft was not transplantable, the
surgeon planned to tell them that the pancreas was misidentified
as debris and disposed of.
The surgeon approached the family in the waiting room and
shared the information as planned. The family replied, “That’s
okay, doctor. What we really wanted was to get Dad off of
dialysis; the pancreas transplant was just a bonus.” The family did
not ask why the pancreas was not transplantable, and the surgeon
did not offer additional details of what had transpired. The
patient subsequently underwent a successful second operation to
transplant a pancreas at the same institution.
Discussion
This case represents a clear-cut, harmful error,
one that existing guidelines say should be disclosed.
Yet most guidelines20 –22 have been silent on what
specific information should be conveyed. The standard of The Joint Commission23 with regard to
disclosure states that patients should be informed
Manuscript received January 6, 2009; revision accepted March 5,
2009.
Affiliations: From the Departments of Medicine, Bioethics, and
Humanities (Dr. Gallagher), University of Washington, Seattle, WA;
the Department of Medicine (Dr. Bell), Beth Israel-Deaconess
Medical Center, Harvard Medical School, Boston, MA; Institute for
Patient Safety Excellence (Dr. Smith), University of Illinois Medical
Center at Chicago, Chicago, IL; Harvard School of Public Health
(Dr. Mello), Boston, MA; and the Departments of Anesthesiology
and Pediatrics (Dr. McDonald), University of Illinois Medical
Center at Chicago, Chicago, IL.
Funding/Support: This study was supported by the Robert
Wood Johnson Investigator Award in Health Policy Research
(Drs. Gallagher and Mello) and the Agency for Healthcare
Research and Quality (No. 1RO1HS016506) [Dr. Gallagher].
© 2009 American College of Chest Physicians. Reproduction
of this article is prohibited without written permission from the
American College of Chest Physicians (www.chestjournal.org/site/
misc/reprints.xhtml).
Correspondence to: Thomas H. Gallagher, MD, Associate Professor of Medicine, University of Washington, 4311 Eleventh Ave NE,
Suite 230, Seattle, WA 98105; e-mail: thomasg@u.washington.edu
DOI: 10.1378/chest.09-0030
about all outcomes of care, including unanticipated
outcomes, and frames the rationale for such disclosure as promoting informed decision making by the
patient. However, the standard does not specify the
content of the disclosure, leaving providers considerable discretion about how much information
should be shared with the patient.
Uncertainty about exactly how much information
to share with patients is one key barrier to disclosure.16,17 Prior research24,25 has suggested that patients value knowing specific information about the
event, including whether an error occurred, why it
occurred, and how it will be prevented in the future.
Physicians, however, often begin disclosure conversations by providing very limited information about
the event and relying on the patient or family to ask
clarifying questions if they want to know more about
what happened.17 This approach may partly reflect
physicians’ awareness that patients vary considerably
in the amount of information they desire in other
areas of clinical medicine. Physicians also might
believe that this “don’t ask-don’t tell” strategy is
consistent with a commitment to full disclosure.
Indeed, the surgeon in this case was prepared to fully
disclose everything that happened if the family asked
why the pancreas was not transplantable. It is possible that the family did not ask follow-up questions
because they considered why the pancreas was “not
transplantable” to be unimportant and, thus, may
have been satisfied with the disclosure as it occurred.
Yet, this strategy of letting the patient or family
determine the content of disclosure through their
questions has significant flaws. An alternative explanation for lack of follow-up questions could be that
family members mistakenly believe that no error
happened or that they are concerned that asking
probing questions might cause problems for them
(especially if they will need to rely on the same
surgeon or institution for the second operation).
Because health-care workers cannot read patients’ or
family members’ minds, they cannot accurately intuit
what the absence of questions means.
New disclosure standards increasingly describe
the key information that should be shared, regardless
of whether the patient or the family asks. For
example, the guidelines for safe practices on disclosure of the National Quality Forum10,26 require that
patients be informed about the facts regarding the
unanticipated outcome and its preventability. In the
case at hand, sharing the fact that the failed pancreas
transplant was preventable might have been all that
was necessary for the family to want to learn more
about the event.
Despite these emerging guidelines, clinicians may
still wonder whether a specific piece of information
needs to be disclosed to a patient. The medical
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Medical Ethics
profession should reach consensus about what constitutes material information in disclosure discussions (ie, information that should be shared with all
patients regardless of whether the patient asks). One
potential standard could be that specific disclosure
content should be considered material if that information were essential for a reasonable patient or
family to be free of fundamental misconceptions
about what transpired.
Ensuring that patients are free of fundamental
misconceptions about what happened not only is an
important goal in and of itself, but also is essential for
informed decision making broadly construed. Although the knowledge that an error occurred may
not influence the patient’s decision about whether to
seek a second pancreas transplant, this information
could help the patient to make an informed decision
regarding whether to have the retransplantation at a
different medical center. Our conception of materiality is consistent with the reasonable patient standard27 that many state courts use retrospectively to
assess the adequacy of informed consent. However,
although legal standards for informed consent focus
on the impact that information might have had on
the patient’s clinical decisions, disclosure of adverse
events and errors can help patients to make more
informed decisions about nonclinical issues as well.
Knowledge of this error would likely help the patient
and family to respond to bills received from the
hospital, for example, reducing the chances that they
would be financially harmed by this event.
Bottom Line
The don’t ask-don’t tell approach in this case was
deceptive. A reasonable family would not suspect
that the pancreas was not transplantable because it
had been discarded or even that an error occurred.
Thus, the reason why the pancreas was not transplantable was material information that should have
been shared, regardless of whether the patient or
family asked.
Case 2: What You Don’t Know Won’t Hurt
You
An 83-year-old longstanding patient at a large medical center
presented to the same center complaining of palpitations of 12 h
duration. Neither her regular cardiologist nor her primary care
physician was available, and she was seen by a covering cardiologist. An ECG showed atrial fibrillation. The finding was presumed to be new; therefore, she was scheduled for electrical
cardioversion the following day without antecedent anticoagulation. The cardioversion was successful, and the patient was
discharged home feeling well. The patient lived with her husband, who was in good health except for mild dementia. The
couple had no children, and no other relatives lived locally.
Eighteen hours after arriving home, the patient experienced a
massive embolic stroke and was taken to a different hospital,
where she died. The patient’s husband subsequently wrote a
letter to his wife’s regular physicians, informing them of her
death and thanking them for providing her with many years of
excellent health care. The letter prompted the primary care
physician to review the old chart, as he recalled that the issue of
atrial fibrillation might have arisen in the distant past. Indeed,
there was an episode of atrial fibrillation documented 10 years
previously. The patient was thought to be a fall risk, so anticoagulation was not prescribed at that time. Subsequent ECGs all
had shown normal sinus rhythm, and the history of atrial
fibrillation was not noted in her current problem list. The hospital
debated at length whether to notify the patient’s widower of this
error in his wife’s care, and ultimately decided that the distress
such disclosure might cause the widower outweighed any potential benefit of disclosure.
Discussion
This patient experienced the following serious
medical error: failure to recognize that the atrial
fibrillation was not new. Had the covering cardiologist discovered the history of atrial fibrillation, routine anticoagulation before cardioversion would have
been recommended, and this would have likely
prevented the subsequent fatal embolic stroke.
Many arguments could be made to support the
decision of the hospital not to disclose the error to
the widower. Chief among them might be concern
for his psychological well-being, underlying dementia, lack of surrogates, and the clinical uncertainty
surrounding the fatal event (ie, the possibility that
the embolic stroke might have been an independent
event unrelated to cardioversion). In such situations,
the reasons not to disclose can look very appealing.
Cases in which an error is not apparent or in which
health-care workers believe that patients or families
might not understand the disclosure pose special
problems for physicians, and data16 suggest that
disclosure is less likely to happen in these instances.
Other reasons may operate more subconsciously, for
example, the desire to avoid a lawsuit, even if
seemingly unlikely in this case, and the embarrassment of the error compounded by the irony of the
widower’s letter thanking the medical center for its
excellent care.
This case invites careful consideration of the different rationales for disclosure and the way in which
this reasoning can influence the disclosure decisions
of institutions. As in the first case, one potential goal
of disclosure is to promote informed decision making.28 In this case, however, the hospital may have
believed that because the patient died, no additional
clinical decisions needed to be made. Although one
could argue that disclosure could help the widower
to make a more informed decision about whether to
seek compensation, institutions typically view the
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possibility that disclosure could prompt litigation as a
factor militating against, not in support of, disclosure. A second potential reason for disclosure is that
discovery of error is inevitable, and being found to
have “covered it up” places the physician and institution in a more compromised position than simply
telling the truth. But, this rationale was not likely
compelling in this case because it was considered
unlikely that this error would be discovered.
The third potential rationale for disclosure centers
on telling the truth for its own sake. But the value of
telling the truth as an ideal when it is directly pitched
against possible psychological harm without potential
benefit poses a more difficult dilemma. The wellmeaning decision makers at this institution were
concerned by the possibility that the truth would do
more harm than good, thus framing the lack of
disclosure in benevolent terms. Benevolent deception, sometimes termed therapeutic privilege, historically has been considered an important part of
medical practice. Some29 have argued that “furthering a patient’s ends may require withholding medical
information,” and some30,31 have suggested that benevolent deception in limited situations may be
justifiable and distinct from lying.
Still, most see therapeutic privilege as a dangerous
paternalism, that is, a slippery slope to be avoided,
especially in today’s medical environment that prioritizes patient autonomy and shared decision making.
Data32,33 from other areas, such as oncology and
end-of-life care, suggest that patients want bad news
even when it would be upsetting. Addressing the
issue of therapeutic privilege, the American Medical
Association34 has taken a stance against withholding
information, encouraging physicians to give patients
the full story.
If the notion of benevolent deception has been
generally discredited, why did it hold such sway in
this disclosure decision? Ultimately, this case reflects
two different types of deception. One, the widower
was deceived about the care his wife had received,
and two, the institution experienced self-deception
regarding the relative benefits and burdens of disclosure. Such self-deception reveals an important
flaw in the disclosure processes at many institutions,
namely, the failure to recognize that disclosure of
error reflects a conflict of interest that can lead
institutions to subconsciously devalue or only partially consider the patient’s interests. In the case at
hand, the incomplete consideration of the patient
perspective led the institution to conclude that the
burdens of disclosure outweighed the benefits, whereas
a more objective assessment would likely have concluded just the opposite.
A key consideration in the management of conflicts of interest is the awareness that conflicts of
interest can distort judgment. Thus, we generally
turn to a neutral party to assess whether a conflict
exists and if so, how to proceed.28 One option for
obtaining such input would be to seek routine
involvement of ethics committees in deliberations
about disclosure. Close collaboration with the ethics
committee could bring increased objectivity to the
institution’s disclosure decisions, especially with those
ethics committees with lay members. The recommendations of ethics committees generally are advisory
rather than binding, which could limit the influence of
an ethics committee on the disclosure process.35 However, given the sensitive nature of disclosure deliberations, the increased involvement of institutional ethics
committees in this process could represent an important first step toward ensuring that the patient’s perspective is more fully represented.
The medical profession should experiment with
creative approaches to counteracting the understandable institutional impulse not to disclose in
cases like this one, such as involving a patient or
family advisory council, patient advocate, or other
patient-representative voices. It would be neither
realistic nor desirable to routinely hand off disclosure
decisions to a third party or to exclude the involved
health-care workers or institution. Yet, when the
patient or family perspective gets lost, the decisionmaking process about disclosure suffers.
An additional institutional consideration is that disclosing the events to the husband would represent a
commitment to transparency, sending a strong message
to staff, and potentially the public, that transparency is
valued at the institution, even when it is difficult or risks
repercussions. Such a firm commitment to transparency is compelling but may create conflicts in cases in
which consideration of the family member’s psychological needs weigh against disclosure. In such cases,
disclosure could potentially subordinate the family
member’s best interests to the pursuit of institutional
benefits. Whether such disclosure honors the principles
of a patient-centered approach and whether this factor
is the most important metric for disclosure decisions
altogether require more thoughtful attention as we
shape future disclosure policies.
Bottom Line
Institutions should be aware that self-deception
can distort the judgments of even well-intentioned
decision makers about disclosure and should ensure
that the patient’s voice is well represented in the
disclosure process. Arguments that the nondisclosure of serious errors represents benevolent deception should be carefully scrutinized.
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Case 3: Shades of Gray
A 60-year-old patient underwent successful coronary artery
bypass graft surgery. The attending surgeon left the operating
room to speak with the family while the cardiac surgery fellow
completed the skin sutures. The perfusionist handed the final bag
of cell-saver blood to the anesthesiology resident for administration. Unbeknownst to the anesthesiology resident, the cell-saver
bag contained a significant amount of air. The anesthesiology
resident started to slowly infuse the blood. The patient’s BP
declined, and the attending anesthesiologist asked the resident to
put the cell-saver blood under pressure to speed up its infusion.
Ten minutes later, the patient had an asystolic cardiac arrest. The
anesthesiology resident thought that he might have observed air
in the IV line, which was quickly flushed with a normal saline
solution.
The surgeon returned to find resuscitation underway. The
anesthesiology resident revealed his concern that air may have
been pushed into the IV line, information that guided the
resuscitative effort. Fifteen minutes later, a normal BP was
restored; however, the patient, previously awake and nearly ready
for extubation, was no longer responsive to verbal or tactile
stimuli.
The patient safety hotline and the patient communication
consult service were notified, and advice was requested. The
attending anesthesiologist and attending cardiac surgeon informed the family that there had been a cardiac arrest and that
many explanations for the arrest were possible, including the
accidental infusion of air through the IV line. They promised to
conduct a full investigation and to remain in continuous contact
with the family.
Overnight the intraoperative data were reviewed and confirmed that the likely presence of intracardiac air had caused the
arrest. The following morning, the attending anesthesiologist
informed the family of the known and suspected circumstances
surrounding the injury, accepted responsibility for the error, and
apologized. Within 24 h, the patient regained consciousness and
was informed of the details surrounding the adverse event.
Discussion
This case highlights how uncertainty may influence the disclosure process. For this injury, several aspects of uncertainty predominated, including whether an error had actually occurred, whether
the error had harmed the patient (eg, whether the air
embolism was etiologically responsible for the sudden deterioration), and how to characterize the
patient’s prognosis in the early stages following the
arrest when he was not responsive to verbal or tactile
stimuli, and long-term recovery therefore was unknown.
An intrinsic challenge to effective, timely disclosure is that full, accurate information about what
happened may not be available immediately following the event. Physicians may feel uncomfortable
about confronting the patient or family while armed
with only partial information, a lack of an understanding of what happened, and uncertainty about
his or her own responsibility for the event. Clinical
uncertainty underscores the benefit of approaching
disclosure as a process, not as an isolated event. The
process can begin with an immediate disclosure that
states what is known at the time, that an unanticipated outcome occurred, that it does or does not
affect how the patient will be treated, and that an
investigation is underway to determine why the
injury occurred. The discussion can later continue
with disclosures about the etiology of the injury and
future prevention.
An initial real-time acknowledgment of an error or
unanticipated outcome honors the obligation of telling the truth and enables the patient or family to
make informed medical decisions. It also helps to
avoid the distrust that may ensue from delayed or
suppressed communication. The initial communication can include an assurance that additional information will be conveyed as it becomes available. At
the same time, an opportunity for a full investigation
relieves the involved providers of a belief that they
have to have all the answers at the time of the initial
family meeting. Connecting the patient and family
with a liaison, as in this case, also demonstrates an
ongoing commitment to open communication and
support. A specific consult service with expertise in
communication and crisis management can assist
clinicians in preparing for disclosure discussions,
provide a designated contact person for patients, and
facilitate ongoing information sharing about the
event and plans for follow-up.36,37
Uncertainty about whether harm was caused by an
error, however, can persist despite comprehensive
investigation and analysis. No standards currently
exist to guide clinicians’ decisions in such cases.
Should the provider share this uncertainty with the
patient or family? How confident must the provider
be that an error occurred in order for a disclosure
obligation to be triggered?
From the patient’s or family’s perspective, ambiguity about whether the injury was attributable to an
error will not seem a valid reason for not providing
all the available information about what happened.
The uncertainty does not change their need for
information that may facilitate informed clinical decisions and alert them to the potential availability of
an avenue for seeking compensation. When healthcare providers include a candid statement of their
level of certainty that an error occurred, they help
the patient and family to weigh these matters. For
example, hearing that the facts about injury causation are murky may dissuade the family from expending energy and resources on malpractice litigation that is unlikely to succeed.
The provider, on the other hand, may believe that
admitting that an error may have occurred in the
absence of persuasive evidence supporting causation
simply opens a can of worms. Speculating about
whether a mistake caused harm exposes the health-
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901
care team to litigation, damage to reputation, and
potential severance of the physician-patient relationship without firm grounds. Although real, these
concerns do not outweigh the patient’s right to
information. Physicians should work closely with
institutional patient safety and quality experts to
ensure that the information that they communicate
to patients about a potential error is as accurate as
possible without allowing such consultation to unduly delay disclosure discussions. Again, communicating the extent of uncertainty surrounding the
injury and maintaining an open dialogue in an
ongoing process of disclosure can help to minimize
the risks to providers.
Bottom Line
Uncertainty is inherent in the practice of medicine, and providers need help with understanding
how to manage discussions about uncertainty with
patients and families. Evolving disclosure policies
must take this reality into account. Policies that
demand a full disclosure in a matter of hours or days
likely will result in an isolated disclosure conversation that is confined to what is reasonably knowable
within that time frame, and often, that will exclude
pieces of information that are important to patients
and families, such as why an injury occurred and
what will be done to prevent it from happening
again. Approaching disclosure as a process, that is,
coupling timely acknowledgment of the unanticipated outcome with full investigation and subsequent disclosure and apology as appropriate, is a
preferable strategy.
Conclusion
The foregoing cases illustrate three of the central
challenges facing health-care providers and architects
of disclosure policies today. First, what information
must be conveyed in a disclosure conversation? When
is an omission misleading, and how much should be left
up to the question-and-answer portion of a disclosure
conversation rather than to the initial statement by the
health-care provider? Second, how does the prospect
that the disclosure itself might unproductively distress
the patient or family affect a provider’s disclosure
obligations, and are providers and their institutions able
to objectively weigh the prospect of patient distress
given their own interest in avoiding admissions of
error? Finally, what should be done when there is
substantial uncertainty about whether an error occurred or whether it caused harm? How do the key
rationales for disclosure (ie, the principle of telling the
truth, the promotion of informed decision making, and
the desirability of avoiding the potential harms associated with a cover-up) come into play in situations of
uncertainty?
Although it may be undesirable to base policy
decisions on hard cases, these three cases shed light
on some of the hobgoblins of effective disclosure
conversations. Disclosure decisions can be clouded
by personal and institutional conflicts of interest and
the very human temptation to answer unresolved
questions (eg, Would this spouse want to know the
truth? Did an error really occur?) in self-serving
ways. By confronting these challenges at the time
disclosure policies are created and disclosure training is conducted, institutions and providers can avoid
ill-conceived and counterproductive decision making
at the bedside later on and help providers to honor
their professional obligations and their patients.
Acknowledgments
Financial/nonfinancial disclosures: The authors have reported to the ACCP that no significant conflicts of interest exist
with any companies/organizations whose products or services
may be discussed in this article.
Other contributions: We thank Carolyn Prouty, DVM, and
Odawni Palmer for assistance with manuscript preparation.
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