Version June 2024
INTRODUCTION — Prior to performing a procedure, the surgeon has an obligation to inform the patient of the benefits and potential harms of surgical treatment. What constitutes informed consent, including proper documentation of the informed consent session, is reviewed separately. (See "Informed procedural consent".)
Surgeons also have a duty to inform the patient of complications that result from surgery. Although surgeons strive in daily practice to avoid harm (primum non nocere), adverse events and unfortunate outcomes occur. As complications arise, surgeons should strive to be transparent with patients about matters related to their care, in a manner that avoids confusion and self-incrimination [1]. A natural tension exists between the surgeon's honest goals of explaining how errors may have occurred and empathizing with the patient and their family or other caregivers, all the while avoiding legal hazards [2].
Silence and secrecy are increasingly considered ethically and legally unacceptable responses to medical injury [3], as can be seen in codes of professional ethics, health care organization accreditation standards, state apology laws, and "disclosure-and-offer" programs implemented by health care systems and liability insurers. The shift from prior practice, often a "deny-and-defend" approach, has not come with particularly effective, streamlined, or reassuring processes for surgeons who are called upon to make disclosures and apologies.
The doctrines of disclosure and apology, including legal and ethical considerations, and a practical approach to guide surgeons through these difficult issues are reviewed in this topic.
DISCLOSURES, APOLOGIES, AND RELATED CONCERNS — Although they are not the same, the concepts of apology and disclosure are frequently mixed together, intertwined as they often are in practice.
Disclosures — Disclosure grew out of the patient-safety focus that followed the 1999 publication from the Institute of Medicine, "To Err is Human: Building a Safer Health System," which uncovered the perils of iatrogenic injury inherent to the health care system [4]. The report eroded the myth of medical-professional infallibility, and the magnitude of the findings led to patient-safety initiatives and demands for increased transparency about medical errors from consumer groups, health care entities, regulators, and legislators. Where adverse events result in patient harm, disclosures are called for by professional ethics codes, institutional accreditation standards, and even some statutory mandates. Surgeons must tell patients what went wrong.
Disclosure duties for surgeons arise when there are errors or complications attributable directly to their acts (or omissions). Such disclosure includes cases where the harm may not be obvious or severe, or where the harm may only become evident in the future [5]. The American Medical Association (AMA) Code of Medical Ethics states in Opinion 8.6 [6]:
●"In the context of health care, an error is an unintended act or omission or a flawed system or plan that harms or has the potential to harm a patient. Patients have a right to know their past and present medical status, including conditions that may have resulted from medical error. Open communication is fundamental to the trust that underlies the patient-physician relationship, and physicians have an obligation to deal honestly with patients at all times, in addition to their obligation to promote patient welfare and safety. Concern regarding legal liability should not affect the physician's honesty with the patient."
In response to medical errors, the AMA Code of Ethics recommends that physicians [6]:
●Disclose the occurrence of the error, explain the nature of the (potential) harm, and provide the information needed to enable the patient to make informed decisions about future medical care.
●Acknowledge the error and express professional and compassionate concern toward patients who have been harmed in the context of health care.
●Explain efforts that are being taken to prevent similar occurrences in the future.
●Provide for continuity of care to patients who have been harmed during the course of care, including facilitating transfer of care when a patient has lost trust in the physician.
Similarly, the Joint Commission Standard RI.2.90 states [7]: "Patients and, when appropriate, their families are informed about the outcomes of care, including unanticipated outcomes." This standard envisions involving "the licensed independent practitioner or their designee" in the disclosure of treatment outcomes, both when favorable and particularly when adverse [7]. It does not, however, expressly require admission or apology. Some states have enacted legislative disclosure mandates for providers in the event of serious errors that harm patients [8]. Furthermore, and perhaps most importantly, disclosure aligns with the ethical principle of patient autonomy that is important in modern-day health care [3]. Patients should be given the information necessary to make health care decisions and to control what happens to them, before and after procedures. (See "Informed procedural consent".)
Apologies — Apologies differ in function from disclosures. Disclosures relate the bare-bones facts of the patient care, whereas remorse and apology are fundamentally about social interaction and relationships [9]. When perceived as authentic, apologies constitute an important "ritual" that has the ability to disarm others of their anger [10]. In addition to the social benefit of helping to restore relationships, apologies can also confer upon both the recipient and the giver a variety of benefits related to wellbeing [10]. However, in the medical arena, an apology, although laudable, has potential unintended consequences.
Apologies can convey empathy, contrition, or both [11]. What is included in an apology can greatly influence whether such statements receive legal protection. The majority of apology laws extend exclusively to expressions of empathy but do not cover statements that include admissions of negligent conduct [11]. In addition, statements of remorse related to conduct also have the potential to affect insurance coverage, as discussed below. (See 'Admissibility in malpractice actions' below.)
There is a significant difference, as it turns out, between an "I'm sorry" that expresses sympathy and an "I'm sorry" that states or implies culpability. This fine distinction is one that has a real impact on how well surgeons can defend themselves in the event of a lawsuit. Apologizing without admission, therefore, may require careful selection of words and phrases.
Admissibility in malpractice actions — A statement of "I'm sorry," whether part of an apology or a disclosure, may become problematic in the event of subsequent legal action for medical malpractice. Specifically, state and federal jurisdictions use certain rules of evidence to govern the admissibility of out-of-court statements by defendants related to apology, offers of compensation, and admissions of fault or wrongdoing; as an example, Federal Rules of Evidence Rule 409, applicable to federal cases, declares that "evidence of furnishing, promising to pay, or offering to pay medical, hospital, or similar expenses resulting from an injury is not admissible to prove liability for the injury" [12,13]. That said, since the overwhelming majority of medical malpractices are heard in state courts, in the absence of a state statutory protection that bars their admissibility, such statements are likely to be allowed into the legal proceedings as at least some evidence against the defendant [14]. In such cases, the surgeon may be construed as admitting that they were wrong in decision-making or in technical performance. If the statement is deemed to be an admission of wrongdoing on the part of the surgeon, the plaintiff may not need to provide additional expert testimony against the surgeon. Thus, the surgeon acts as an expert against himself/herself.
Case examples:
●In one case [15], the court held, in a wrongful death action, that the surgeon's statements to the family directly after a surgical procedure resulting in the death of the patient were admissible as an admission of fault despite the state's apology law. The surgeon's statements in question, as testified to by the family members to whom they were uttered, were: "It's my fault. I take full responsibility." The court ruled against the surgeon, noting that the state's apology statute covered expressions of "apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence, but not admissions of fault."
●In another case [16], the court found that a statement, in an otherwise redacted letter, was admissible as evidence in a subsequent lawsuit filed by the patient for emotional distress. The letter was from the medical center to the patient in response to the patient's grievance regarding the surgeon's preemptive disclosure of a cancer diagnosis to the patient prior to the receipt of biopsy results. The statement read: "The surgeon 'realizes now that prior to sharing his clinical impressions with you, he needed to wait for the results of the biopsy to confirm what the cancer was.'" The statement was admitted into evidence, despite the existence of a state apology statute and a rule of evidence barring admission of offers of compromise to resolve disputes. The statement was allowed based on the fact that the apology statute did not protect expressions of fault.
Apology laws — Thirty-eight states in the United States and the District of Columbia have enacted some sort of apology law that provides protection against the admissibility of statements of sympathy or condolence by those who become defendants in subsequent lawsuits [17]. However, the types of statements protected by these statutes vary from jurisdiction to jurisdiction. Many such statutes expressly cover only empathetic conveyances [2]. A number are silent as to the admissibility of utterances by the defendant that can be construed as admissions of fault. Some jurisdictions make it clear that comments related to fault, even if combined with or part of an apology, are admissible [2,18]. In addition, some jurisdictions include particulars regarding when and to whom the statements can be made [10,19].
Even when a state has an apology law, the admissibility and evidentiary treatment of statements of apology by defendant-surgeons range broadly [20]. It becomes a case-by-case analysis that turns on a multitude of factors, including the protections provided by the jurisdiction's apology law; the specific facts of the case at bar, including the wording of the statement; and the evidentiary rules and legal arguments made as to how the statement is to be used. Thus, the choice of words used when speaking to patients and their families about untoward events may become the subject of intense scrutiny, long after the fact.
The AMA has urged physicians to seek changes to the current legal system to ensure that errors that exist in health care can be safely and securely reported and studied as a learning experience for all participants in the health care system without the threat of discoverability, legal liability, or punitive action [21]. Physicians should familiarize themselves with the relevant laws and regulations of the states in which they practice.
Apology programs — Over time, apology programs have gained attention. These include disclosure-and-offer programs (also known as disclosure, offer, and apology programs) [22] and communication-and-resolution programs [3], which include a prompt and full disclosure of the error, an apology, and an early offer of remediation that includes waiver of medical bills, out-of-pocket costs, and payment for pain and suffering [23]. There are conflicting opinions as to how much help or harm results from these programs [24].
Some studies have found that full apologies coupled with compensation can prevent the filing of a lawsuit and may lead to lower payouts than when the physician is actually sued. However, the providers giving rise to these limited data are generally governmental institutions, such as Veterans Administration hospitals, or large, state-affiliated academic medical facilities [23]. Few private health care institutions have adopted such programs, although they are increasing in number [25]. At least one demonstration project has experienced challenges when dealing with independently employed physicians, where there is the need to coordinate multiple malpractice insurers [23,26]. Often, the involved physician has one insurer and the institution has another, and that alone may be the source of conflict [27].
When entertaining the idea of offering a settlement, surgeons should also remember that malpractice insurance carriers must report any payouts made in the name of the surgeon to the National Practitioner Data Bank and to the state medical board [23]. Settlements can also have an impact on hospital medical staff credentialing. Furthermore, disclosure-and-offer approaches are consistent with the type of apology that includes both empathy and admission of negligence, and as a result, some of the statements made during the process may be admissible, to the surgeon's detriment, if a settlement is not reached and a lawsuit is filed [23].
One might think that an early apology would allow a surgeon to avoid litigation; however, a theoretical study has questioned that conclusion. The study predicted that broad adoption of such programs might prompt an increase in litigation volume and costs, rather than deter it [28]. Indeed, the data suggested that clinicians, particularly nonsurgeons, are more likely to face malpractice claims, more likely to see a rise in malpractice insurance costs, and more likely to practice defensive medicine under the "protection" of apology laws [29,30]. Thus, an apology, even a carefully crafted one, may not improve a surgeon's chance of avoiding a lawsuit, may instead increase that chance, and may result in a court's finding that the surgeon has actually admitted his/her own fault.
RECOMMENDED PROCESS — In the case of an event that triggers the need for disclosure or an apology, the following issues should be considered.
Informed consent — A well-executed informed consent session in advance of a surgical procedure will help to create realistic expectations for the patient, as it will alert that patient to the very real possibility that complications may arise. Early warning makes disclosure of later adverse outcomes less of a surprise for patients, and disclosure then fits more easily into the narrative that surgical procedures are not free of risk and that good results are not guaranteed. (See "Informed procedural consent".)
Initial discussion — At the initial contact with the patient and/or family when leaving the operating room, present the facts (as known at that time) of the surgical case and leave the remainder of the discussion until more is known. Promise the patient/family that a comprehensive investigation into the specifics of the procedure will be undertaken and another discussion will follow. The surgeon should focus the initial discussion on the current medical needs of the patient, promising to remain involved in the patient's care. The patient and family should be told that there will be additional conversations, the timing of which will depend upon what is known about the facts of the case as soon as those facts are fully known. A more formal conversation should then be scheduled [31].
Review policies — Before engaging in any additional communication regarding the event, review malpractice insurance contract provisions and contact the insurer. Malpractice insurers typically require their insureds to be cooperative and to refrain from engaging in actions that would be prejudicial to defending claims per the contractual terms and conditions of the policy [32]. Conduct in violation of the policy's terms and conditions can invalidate coverage [12]. Although under some policies an apology may not be deemed a violation, a statement that constitutes an admission of fault could lead to a denial of coverage by the insurer [12]. As a result, it is critical that the insurer be consulted prior to patient discussions, and it is advisable to receive the insurer's permission to participate as well as its approval of the proposed statements. The agreed-upon script should then be conveyed to the patient, insofar as it is possible, without coming across as rehearsed or insincere [12].
Involve risk management — Contact the hospital or health system counsel, as well as risk management if the incident occurred in an institutional care setting. Because independent-contractor surgeons and health care institutions are often insured by different carriers and policies, coordination between malpractice insurers may be necessary. Surgeons should keep in mind that the institution's legal interests and their own legal interests might diverge. In such instances, surgeons might consider obtaining personal legal counsel before moving forward. Hospital/health system personnel, such as in-house counsel and risk managers, can also be helpful because, as a rule, they have greater expertise in handling such communications than do individual surgeons. If these first two steps become time-consuming, it may be wise to contact the patient and family to assure them that the medical aspects of the case are being investigated to see what happened, and that the surgeon and hospital representatives will speak with them again when all facts are known.
Participants and timing — Select key participants, as well as a suitable location and time. If a determination is made that the incident requires disclosure and/or an apology, a decision must be made about participants and their role in the dialogue. Those participants might include the surgeon, care-team members, and institutional representatives, as well as the patient and his/her invited guests. It is important to keep the participants to a minimum number so that neither side feels overwhelmed. First and foremost, care must be taken with regard to patient confidentiality and the restrictions imposed by the jurisdiction's apology law, as some apology laws limit who may be among the apology recipients [33]. Moreover, considering the goals of autonomy (as well as privacy mandates surrounding patient information), the competent patient must be the one to decide who, if anyone, should be present. (See "Informed procedural consent".)
Once participants have been appropriately identified, a location, date, and time must be selected. If possible, the location should be somewhere private and tranquil. The discussion should be held as soon after the incident as possible, while allowing for the foregoing steps and for adequate review of the incident itself. Prior to any meeting, those involved should possess a thorough understanding of the medical facts, and the case may benefit from review by an outside, independent surgeon. Thus, while it is important to proceed expeditiously, it is also important to know the case well. One must be aware that a few jurisdictions set outer bounds on when this dialogue must take place in order to retain any evidentiary protections [33]. Suffice it to say, gathering information and making certain all the right people are contacted and in agreement about time, place, and content will take time. To make the communication meaningful and as genuinely engaging as possible, all efforts should be made to keep the process in motion and to keep any delay to a minimum. All present should be aware that more than one follow-up meeting may be required to complete the discussion.
Statement and delivery — Carefully construct a statement and the parameters of the dialogue, and ensure calm, sympathetic, and sincere delivery. To avoid possible liability, based at least in part on the statements made, the apology in most jurisdictions should be limited to an expression of sympathy and compassion [34]. This, however, may be insufficient from the perspective of the recipients. Saying "I'm sorry" alone is often inadequate to provide the kind and amount of information that patients and families desire following an adverse event [23]. The consequence can be a particularly challenging dialogue, and if health care providers perceive legal protection from disclosure laws as inadequate, or if they are uncertain of the coverage provided by their liability insurance, they may choose not to disclose all information requested by their patients [35]. This can actually aggravate an already fraught situation because patients (and their families) expect a comprehensible and responsive dialogue [35].
In these highly sensitive communications, strong emotional reactions are sometimes triggered in participants who may already be quite unhappy [19]. While surgeons recognize the importance of such discussions with patients, they often lack training in handling such extremely difficult dialogues, particularly when there is also awareness that their personal interests may conflict with others at the table [19]. And still, it bears keeping in mind that defensive or insincere apologies can exacerbate the situation [19,34].
The surgeon should avoid speculation or deviation from known facts, and avoid inconsistencies, because if such statements are ultimately admitted into evidence in a subsequent legal action, they can look suspicious to a jury [36]. Following the initial dialogue, further review, such as a root-cause analysis, or other quality improvement processes may be necessary. The results may lead to additional patient dialogues.
Finally, discussions should include next steps in the care plan and appropriate treatment options. This promotes patient autonomy in decision-making and focuses on the patient's needs moving forward. In addition, this part of the discussion should include plans for prevention of similar events in the future, as patients often wish to know that their experience will inform future decisions and protect future patients. If the physician/hospital system desires to, they may offer compensation as part of their disclosure-and-offer program.
Documentation and follow-up — The dialogue should be objectively documented (in the patient's medical record if the discussion happens while the patient is in the hospital), and such documentations should include the time, date, and location of the meeting; the individuals present; the disclosures made; the reactions of the patient and/or the patient's family; any promised follow-up; and next steps in treatment, if any.
SUMMARY AND RECOMMENDATIONS
●Surgeons have a duty to communicate complications that result from surgical procedures, but this places the surgeon in a difficult position. On one hand, the surgeon is encouraged to disclose adverse outcomes, and his/her human instinct is to empathize with the patient and their families. On the other hand, surgeons are warned that apologies and disclosures can be seen as inviting lawsuits and lessening the ability to defend oneself if sued. What results is a surgeon who is torn between doing what is right (ethically, morally, and by mandate) and doing what seems best for self-preservation as dictated by defensive instinct and, often, by insurer policy. (See 'Introduction' above.)
●What constitutes a protected apology in the medical setting must be carefully considered and composed, often with the aid and approval of others, including malpractice insurer personnel, hospital counsel, and, perhaps, the surgeon's own legal counsel. Care must be taken that the resulting dialogue does not lose the intended moral, social, and transactional benefits. (See 'Recommended process' above and 'Disclosures, apologies, and related concerns' above.)
●Surgeons must learn to convey to the patient such scripted disclosures and apologies with sincerity. It can be very difficult to be spontaneous, forthright, fully human, and fully explanatory when adhering to a script designed to satisfy one's insurer and avoid self-incrimination. It is also very important to remember that the surgeon has an emotional stake in the process. (See 'Recommended process' above.)
●The American Medical Association has urged physicians to seek changes to the current legal system to ensure that errors that exist in health care can be safely and securely reported and studied as a learning experience for all participants in the health care system. (See 'Disclosures, apologies, and related concerns' above.)
●Surgeons are encouraged to ask their hospitals and insurers to allow greater latitude in apology discussions. Promoting freer, more open, and more honest discussions with disappointed patients and families should inure to the benefit of surgeon and hospital alike, but it may require a concerted effort to change the current culture of self-protection for all involved. (See 'Recommended process' above.)
ACKNOWLEDGMENT — The editorial staff at UpToDate acknowledges Michele Mekel, JD, MHA, MBA, who contributed to an earlier version of this topic review.
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