By Charles D. Randolph ’19
Medical professionals all agree physician medical errors occur, and they are often linked to significant adverse events. However, there is still significant disagreement regarding how often these errors occur and what to do after a physician error occurs. First, we must define the term “medical error.”
Some argue for a broad definition (such as that used in the controversial Institute of Medicine report “To Err Is Human”)1, equating medical error to preventable adverse events. Under this definition, all adverse events that could have been prevented are considered medical errors even if the physician practiced at or above the standard of care. This leads to the rather shocking conclusion that up to 98,000 deaths per year in the U.S. are caused by medical errors.
Others argue for a much more narrow definition, using the legal language of malpractice to guide them, requiring duty, breech, causation, and harm.2 However, for the purposes of this discussion, I would like to argue for an even broader definition: “a commission or an omission… that would have been judged wrong by skilled and knowledgeable peers at the time it occurred, independent of whether there were negative consequences.”3
As a physician, the term “medical error” becomes personal. It means that “I” or someone on “my” health care team made a mistake. Sometimes these mistakes are major (failing to provide a full informed consent, forgetting to file a report on child abuse, or missing a key diagnosis). Sometimes these mistakes are minor (forgetting to reorder daily labs after the order expired or making a patient NPO when their surgery for the next day has been delayed). Mistakes may be unintentional, intentional, or due to momentary lapses of judgment. Under this definition, a medical error is not defined by its outcome. It is not defined by the standard of care. It is defined by the physician and their peers when they internally reflect and realize they could have or should have done better. Under this umbrella term, specific types of errors can then be identified. Misdiagnosis, medication error, near-miss, iatrogenic injury, failure to screen, overutilization of care, underutilization of care, etc. The list goes on and on. We see these medical errors every day in every practice setting. But what do we do after we realize we made a mistake?
After a medical error, physicians often struggle with the question of what to tell the patient. The unspoken policy for many years has been to hide or deny errors. The primary motive for this practice is fear of litigation, which is strongly ingrained into physician culture. We are often told it is better to practice “defensive medicine” than “good medicine” because even good doctors get sued. However, a more careful examination will reveal that defensive medicine is simply bad medicine. It places a strain of extreme caution on the physician-patient relationship, it demands unnecessary tests driving up health care costs, and it teaches physicians to hide and deny mistakes. Slowly, a shift has been taking place, and it is now generally considered ethically necessary to disclose significant medical errors to the patient. This has been reiterated by numerous professional organizations, including the AMA code of ethics (opinion 8.6).4 The code of ethics emphasizes the important values of honesty, trust, patient autonomy, and patient safety, and it stresses that patients have the right to know about the past and present medical condition. Of note, it specifically states, “Concern regarding legal liability should not affect the physician’s honesty with the patient… even when new information regarding the medical error will not alter the patient’s medical treatment or therapeutic options.” Despite this strong ethical argument for disclosure, studies indicate that many physicians fail to disclose errors to their patients.
In a large national survey of both physicians and non-physicians who had suffered an unanticipated outcome in their or their loved ones’ care, only 30 percent reported receiving an explanation or apology for the error.5 In a study looking at malpractice cases, only 15 percent of defendants reported receiving an apology by the physician.6 Clearly, many physicians fail to disclose, explain, and apologize for their medical errors. But in another study the majority of physician respondents reported that they wanted to apologize to their patients but did not do so out of fear of lawsuit.7 However, this fear may be misplaced.
What many physicians may not realize is that 36 states (including California) protect apologies as inadmissible evidence in court. One example is California Evidence Code §1160: “The portion of statements, writings, or benevolent gestures expressing sympathy or a general sense of benevolence relating to the pain, suffering, or death of a person involved in an accident and made to that person or to the family of that person shall be inadmissible as evidence of an admission of liability in a civil action. A statement of fault, however, which is part of, or in addition to, any of the above shall not be inadmissible pursuant to this section.”8 These laws have been supported by physicians and medical groups nationally as an important protection allowing health care providers to apologize without fear of being sued.
Furthermore, beyond the ethical mandate, there is a growing legal mandate for disclosure. An early case regarding disclosure was Simcuski v. Saeli (New York Court of Appeals; 1978). In this case the defendant suffered a serious complication of surgery that was never disclosed by the surgeon. The case was initially dismissed as it fell outside the three-year statute of limitations for medical malpractice. Yet the appeals court held that the lack of disclosure constituted fraud, and thus the case was within the six-year statute of limitations for fraud.9
More recently, 10 states have passed laws mandating full disclosure by the physician of all unanticipated outcomes that occur under his or her care. These states include Oregon, Washington, Nevada, Florida, Tennessee, South Carolina, Maryland, New Jersey, Connecticut, and Pennsylvania. These laws have come under some scrutiny for lacking provisions for effective enforcement, but they represent a clear shift legislatively. It would be reasonable to predict that similar laws will be passed soon in many other states, and the legal mandate for disclosure will continue to grow. Other important bodies, including the Joint Commission and the National Quality Forum, call for full disclosure being established as the national standard of care. As disclosures become established as the standard of care, any physician that fails to disclose will open themselves up to risk of lawsuit.
Now we are seeing an increasing number of hospitals embrace policies that support full disclosure. These are called compensation and resolution programs (CRP). They were piloted at Stanford, University of Illinois, and University of Michigan and then expanded to 14 other AHRQ sites. Under these programs all unanticipated outcomes and medical errors are disclosed immediately, and patients are offered compensation up front. Despite concern that these programs would be expensive and lead to both increased payments and lawsuits, studies at these sites suggest the opposite. Many of the sites have shown CRP implementation is associated with lower rates of new claims and legal defense costs.10 And none of the hospitals experienced worsening liability after CRP implementation.11 This suggests that other hospitals can incorporate similar policies that increase disclosure, respecting both legal and ethical mandates to disclose, without increasing their liability and costs. Not only is this beneficial for the patients, but this is beneficial for providers as well. Health care providers are now recognized to be the “second victim” of a medical error.12 Many providers reported feeling increased anxiety and fear, having difficulty sleeping, and having decreased job satisfaction following a significant patient safety event. By adopting open disclosure policies, we can better support both patients and health care providers as they struggle through difficult times.
In conclusion, medical errors need to be disclosed to maintain the trust and honesty inherent to the physician-patient relationship. There is a strong ethical mandate for disclosure and a growing legal mandate as well. Full disclosure includes an explanation, an apology, and a discussion of how to prevent future events. Historically, physicians have failed to provide full disclosure, and when people start to compromise in the health care setting, it can create a culture void of integrity. As physicians, we should hold ourselves and our colleagues to the highest standards of care. By creating a culture that does not stigmatize medical errors but rather recognizes that we are all human, we can achieve a promising future for medicine.
Dr. Randolph is doing a family medicine residency at Valley Medical Center in Renton, WA. He wrote this article as a senior for his Law and Medicine course taught by Donna L. Carlson ’69.
Endnotes:
1. Kohn LT, Corrigan J, Donaldson MS. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press; 2000.
2. Bal, B. S. (2008). An Introduction to Medical Malpractice in the United States. Clinical Orthopaedics and Related Research, 467(2), 339-347. doi:10.1007/s11999-008-0636-2
3. Wu AW, Cavanaugh TA, McPhee SJ, Lo B, Micco GP. To tell the truth: ethical and practical issues in disclosing medical mistakes to patients. J Gen Intern Med. 1997; 12(12):770-7759436897
4. https://www.ama-assn.org/delivering-care/ethics/promoting-patient-safety
5. Blendon RJ, DesRoches CM, Brodie M, Benson JM, Rosen AB, Schneider E, Altman DE, Zapert K, Herrmann MJ, Steffenson AE. Views of practicing physicians and the public on medical errors. N Engl J Med. 2002 Dec 12; 347(24):1933-40.
6. Vincent C, Young M, Phillips A. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet. 1994 Jun 25; 343(8913):1609-13.
7. Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients’ and physicians’ attitudes regarding the disclosure of medical errors. JAMA. 2003 Feb 26; 289(8):1001-7.
8. https://codes.findlaw.com/ca/evidence-code/evid-sect-1160.html
9. Simcuski v. Seali. Court of Appeals of the State of New York. May 4, 1978. 44 N.Y.2d 442 (N.Y. 1978)
10. Kachalia A, Kaufman SR, Boothman R, Anderson S, Welch K, Saint S, et al. Liability Claims and Costs Before and After Implementation of a Medical Error Disclosure Program. Ann Intern Med.;153:213–221. doi: 10.7326/0003-4819-153-4-201008170-00002
11. Kachalia, A., Sands, K., Niel, M. V., Dodson, S., Roche, S., Novack, V., … Mello, M. M. (2018). Effects Of A Communication-And-Resolution Program On Hospitals’ Malpractice Claims And Costs. Health Affairs, 37(11), 1836-1844. doi:10.1377/hlthaff.2018.0720
12. Waterman, A. D., et al. (2007, August). The emotional impact of medical errors on practicing physicians in the United States and Canada. The Joint Commission Journal on Quality and Patient Safety, 33(8), 467–476.