Ethics and Error in Medicine

Fritz Allhoff, Sandra Borden, Sandra L. Borden

• Publisher: Routledge
• Year: 2019
• Print ISBN: 9781032176826
• eBook ISBN: 9780429561085
• Edition: 1
• Topic: Philosophy
• Subtopic: Ethics in Medicine

This book is a collection of original, interdisciplinary essays on the topic of medical error. Given the complexities of understanding, preventing, and responding to medical error in ethically responsible ways, the scope of the book is fairly broad. The contributors include top scholars and practitioners working in bioethics, communication, law, medicine and philosophy. Their contributions examine preventable causes of medical error, disproportionate impacts of errors on vulnerable populations, disclosure and apology after discovering medical errors, and ethical issues arising in specific medical contexts, such as radiation oncology, psychopathy, and palliative care. They also offer practical recommendations for respecting autonomy, distributing burdens and benefits justly, and minimizing injury to patients and other stakeholders. Ethics and Error in Medicine will be of interest to a wide range of researchers, students, and practitioners in bioethics, philosophy, communication studies, law, and medicine who are interested in the ethics of medical error.

1 Introduction

Medicine, Mistakes, and Moral Evaluation

Sandra L. Borden

So often it is the little things.

A sophisticated computer-based system to match organ donors with organ recipients. A world-class tertiary medical facility. A team of expert surgeons. A rare heart–lungs combo that fit the cavity of a 17-year-old girl. Speedy transportation of the donated organs synchronized with the removal of the teenager’s failing ones. Perfectly executed implantation of the donated organs.

The transplant surgeon, Dr. James Jaggers, takes the patient off bypass, ready to close the incision. Everything looks set for the medical miracle that drove Jésica Santillán’s family to smuggle her over the border from Mexico and got her school and community in North Carolina to rally around her. And then the blood bank at Duke University Hospital informs the operating room that the organs are the wrong blood type (Diflo 2006, 73).

After urgent treatments to prevent hyperacute rejection of the donor’s type-A organs, Dr. Jaggers immediately went to Jésica’s family and personally informed them of the mistake; he also informed the United Network for Organ Sharing (UNOS). Duke, however, did not make a public statement about the error for several more days. Nearly two weeks after the first surgery and a TV plea by Jésica’s mother, a new, blood-compatible heart and lungs became available for Jésica, who was now near death. Dr. Jaggers obtained the family’s consent for a second surgery with the help of a family friend because the Santilláns did not speak English (Kopp 2003).

Fewer than 24 hours after the second transplant, Jésica suffered from bleeding and swelling in her brain, and, soon after, her brain stopped functioning. She was taken off life support and pronounced dead at 1:25 p.m. on February 22, 2003 (Kopp 2003).

A number of individuals at Duke, UNOS, the Boston hospital where the donor was treated, or the local organ procurement organization could have checked to make sure the donated organs matched Jésica’s type O-positive blood type before the surgery. But no one did. Carolina Donor Services did not ask for Jésica’s blood type before releasing the organs, as required by UNOS policy. Dr. Jaggers did not ask the donor’s blood type as is standard practice. The cooler prepared for the donated organs was not labeled with the donor’s blood type as required under transplantation protocols. Even if it had, the procuring surgeon did not know what Jésica’s blood type was (Kopp 2003; Diflo 2006).

Everyone was focused on the amazing high-wire act of organ transplantation. Meanwhile, no one made sure there was a net on the ground before the act got started.

Attention to Patient Safety

Just four years before Jésica’s transplant, the U.S. Institute of Medicine (IOM) issued the landmark report To Err is Human: Building a Safer Health System. The IOM report marked the unofficial beginning of the patient safety movement. Among other impacts, the report has been associated with a significant increase in the number of research articles published about patient safety, as well as in the number of federal grants awarded on the same topic (Stelfox et al. 2006). Hospitals and health-care professionals have instituted a number of interventions to improve patient safety, such as the 2003 Michigan Keystone project for reducing IV line infections and other common ICU complications. Such checklists, along with information technology and other safety measures targeting systemic weak spots, have also been institutionalized since the report (for a summary of reforms, see Chapters 3 and 9). Nevertheless, the incidence of medical error continues to be alarmingly high.

Error is defined in the IOM report as “Failure of a planned action to be completed as intended or use of a wrong plan to achieve an aim” (Kohn, Corrigan, and Donaldson 2000, 210). Although this definition does not hinge on the occurrence of patient injury, or “adverse events,” nevertheless patient safety advocates are quick to point out the toll medical error has on patients.¹ According to a 2016 analysis by Johns Hopkins experts, nearly 10 percent of all deaths in the United States are estimated to be the result of medical errors; the number of deaths attributable to medical error is exceeded only by heart disease and cancer. And that is not accounting for the fact that conventions used for billing codes and death certificates may be systematically undercounting medical error deaths (Makary and Daniel 2016).

Those dedicated to the IMO report’s systems approach for preventing and catching medical errors (discussed in more detail later in the chapter) are hampered by a number of factors. These include misguided efforts to blame and punish individuals, the decentralized way in which health care is delivered and purchased in the United States, and the perverse incentives that exist in health-care organizations to take shortcuts, underreport errors and circumscribe systemic improvements in view of pragmatic considerations (Bosk 2006; Kohn, Corrigan, and Donaldson 2000). In addition, another major recommendation of the IMO report—toughening laws and regulations to exert external pressure on health-care organizations to improve their performance—has not gotten much traction beyond the passage of a patchwork of state laws requiring reporting of hospital-acquired infections and other selected medical errors (Editorial Board 2009).²

Ethical Principles in Medicine

Given that the incidence of medical error continues to be high, it is somewhat surprising that medical error has received relatively little scholarly attention in the last decade. Even less has been written about the ethical issues raised by medical error. The purpose of this volume is to bring much-needed attention to this context.

Beauchamp and Childress’s (2012) Principles of Biomedical Ethics, now in its seventh edition, is the most widely used ethical framework in medical ethics. The framework proposes four general principles reflecting multiple theoretical approaches: respect for autonomy, non-maleficence, beneficence, and justice. All except justice are focused primarily on the patient. Respect for autonomy concerns the patient’s freedom to choose for oneself without interference from others or under conditions that limit meaningful choice. Non-maleficence concerns providers’ obligation to refrain from intentionally injuring patients. Beneficence requires helping patients by promoting good or preventing or removing harm. Justice concerns the fair and equitable treatment of all members of a society or system based on what they are due, as well as the fair distribution of benefits and burdens within that society or system.

These broad norms can be further specified into moral rules reflecting the particulars of the medical context. For example, Beauchamp and Childress (2012) propose moral rules for autonomy concerning informed consent for medical treatment. The general principles may conflict in practice; if they cannot be balanced, one must determine which obligation is overriding in that specific situation. Here, Beauchamp and Childress model their approach after W.D. Ross’s distinction between a prima facie obligation—one that is binding all things being equal—and an actual obligation—one that is binding all things considered; that is, in view of the relative weight of all the relevant obligations in the particular circumstances.

The framework relates the four principles and their moral rules to virtues in biomedical ethics, as well as professional–client relationships and various ethical theories. In sum, it aims to provide a comprehensive account of applied ethics in medicine (and research). As such, Beauchamp and Childress (2012) have adjusted the framework over the years in response to criticism, and scholars have been interested in testing the framework empirically (see, e.g., Ebbesen, Andersen, and Pedersen 2012on the principles’ cross-cultural applicability). Because of its wide-ranging influence and its aspirations to provide a comprehensive approach to biomedical ethics, it is not surprising that a number of the contributors to this volume use Beauchamp and Childress’s framework to consider a number of broad ethical questions pertaining to medical error, including:

• Who count as stakeholders with interests that need to be considered when preventing or responding to medical error based on the principles of autonomy, non-maleficence, beneficence and justice?
• When responding to medical error, is it just to blame or punish those responsible for “human error” in complex systems characterized by flaws attributable to no one in particular?
• How do we go about fulfilling beneficence and non-maleficence when it comes to medical error, given the inevitable tradeoffs?
• To what degree does the context for moral action constrain moral choice, and thus limit the autonomy of those who might be held responsible for medical errors? And if individuals are not fully responsible for those errors, then who is?

Responsibility for Medical Error

When we hear about medical errors, it is those rare, catastrophic cases, such as Jésica’s, that explode into public consciousness precisely because they are rare and catastrophic. Nevertheless, her case is useful for illustrating a number of important ethical considerations concerning medical error. Among these is the importance of personal responsibility as well as its limits. Although experts agree that medical mistakes, as a rule, cannot be simply attributed to careless, incompetent or malicious providers, medical error may nevertheless feel like a betrayal of trust. Patients in pain and fear literally put themselves in the hands of highly trained health-care providers with the confidence that they can rely on their expertise and experience. Providers’ professional training emphasizes their fiduciary relationship with patients given this asymmetry; hence, the obligation to always prioritize the patient and to act in her best interest (Bosk 2006).

In an interview with CBS correspondent Ed Bradley (Kopp 2003) on 60 Minutes, Dr. Jaggers recalled with remorse that decisive moment when he accepted the first organ donation:

I’m ultimately responsible for this because I’m Jésica’s doctor and I’m arranging all this. But honestly, I look back, and yeah, if I’d made one more phone call or if I had told somebody else to make a phone call or done something different, maybe it would have turned out differently. But you know, those are all 20/20 hindsight.

(Kopp 2003, paragraph 19, sic)

As tempting as it is in individualistic cultures to look for specific persons to blame, however, subsequent analyses of what went wrong concluded that the medical error was the result of breakdowns in both local and national systems. Analysts identified a number of contributing factors, including wrong assumptions, failure to follow protocol, communication lapses, poor coordination across institutions and providers, and time and resource constraints. Add to that list the sheer difficulty of minding all the details involved in such a complex procedure as an organ transplant, let alone one that is performed as infrequently as a heart–lungs transplant. Transplant surgeon Thomas Diflo wrote of the case years later:

Transplantation in the United States, particularly deceased-donor transplantation, has become an exquisitely choreographed dance between the listed patients, their transplant physicians and surgeons, the OPOS, the hospitals where the donors have been treated, and the donor families. The logistics are staggering, and I am frequently amazed that the system works at all.

(Diflo 2006, 72)

And, so, little things—unnoticed, unexamined, innocuous on their own, but of outsized importance when combined—undercut the best efforts of the most professional and dedicated providers and health-care facilities. Root-cause analyses of medical errors, such as those in Jésica’s case, almost always converge on systemic explanations: “The attribution of the accident to ‘human error’ comes from the linking together of complex systems failure and hindsight bias during post-accident review” (Cook 2006, 46,). Implicit bias and other known sources of medical error may be baked into the very technologies, protocols, discourses, and role expectations that characterize health-care delivery no matter where a patient receives treatment. Therefore, it is not enough to examine the individual decisions medical providers make. We also need to pay attention, as Jésica’s case illustrates, to professional and institutional structures.

Silke Schicktanz and Mark Schweda (2012) argue that Beauchamp and Childress (2012) do not systematically conceptualize “responsibility” even though it seems basic to their account. Schicktanz and Schweda propose multiple “responsibilities” in bioethics based on a relational model of moral agency. These include a collective model of responsibility that may be relevant here:

If we have good reasons to believe that an action was based on the condition of a joint commitment or a system effect that goes beyond the impact of single actors, we can identify a collective as agent and therefore also claim collective responsibility. This is even more so if collectives possess economical, structural, or political power.

(135)

The IOM report, in fact, warned that patient safety could only be improved using a systems approach: “The problem is not bad people; the problem is that the system needs to be made safer” (Kohn, Corrigan, and Donaldson 2000, 49). In Jésica’s case, there was a geographically dispersed organ transplant system, its computer-based matching system, and the systems within the donor hospital and the recipient hospital, including the equipment, the operating rooms and other physical spaces, the providers, the communication among them, and policies within all these structures. In accidents—or harmful system failures—a number of things go wrong and combine in ways that were not (and rarely could have been) anticipated. These things gone wrong are errors. Multiple errors build up into serious events that would not have occurred absent that particular combination of factors. Examples of accidents mentioned in the report include the Three Mile Island nuclear accident and the explosion of the Challenger space shuttle.

Because of the unique combination of factors that result in accidents, the report noted that system adjustments to correct for “active errors” in medicine—such as accepting an organ bloc for transplant that was incompatible with the recipient’s blood type—are unlikely to prevent similar accidents in the future. Rather, system interventions are more likely to nip in the bud “latent errors” inherent in organizational design, staff scheduling, and other aspects of the system itself. This is important, though, because latent errors can lead to active errors. To quote from the report again, “The active error is that the pilot crashed the plane. The latent error is that a previously undiscovered design malfunction caused the plane to roll unexpectedly in a way the pilot could not control and the plane crashed” (55). In Jésica’s case, latent errors included lack of redundancy in the processes requiring blood type matching between organ donors and recipients and work-flow routines that had normalized leaving off the blood-type label from coolers storing donated organs (Bosk 2006). If it had not been Dr. Jaggers and Jésica’s other providers, it could well have been other operators in the system, given these flaws.

Ethical Précis

Aside from the complexities involved in conceptualizing and assigning moral responsibility, Jésica’s case illustrates a number of other important ethical considerations concerning medical error. These include:

• The possibility for error from preventive treatment and diagnosis to treatment and follow-up care (Kohn, Corrigan, and Donaldson 2000, 4). The scenario in which a team of surgeons gives a patient organs that are incompatible with her blood type is precisely the kind of scenario we imagine when thinking about medical error. But, as we saw in this case, medical error may happen well before treatment—while diagnosing symptoms, obtaining informed consent for medical procedures or making notes in a patient’s chart. Medical error can happen after treatment as well, as reflected in the high maternal mortality rate in the United States compared to similar countries (Sawyer and McDermott 2019). Vigilance is key at every stage of the patient’s journey through the system.
• Harm caused by medical errors; i.e., “adverse events.” A tendency toward error, or committing a fundamental error of the sort that Dr. Jaggers did, are morally problematic aside from any resulting consequences. This is because they indicate deficiencies in standards of excellence to which health-care providers have committed themselves and given the rest of us reasonable grounds to count on. However, errors that do result in harm, especially harm to the very persons who are supposed to be cared for by health-care providers, seem especially egregious.
• The range of stakeholders implicated and considerations for treating all with fairness and respect. Medical ethics rightly centers patients as stakeholders in health-care decisions, as they are the most vulnerable in this setting, dependent on the judgment and goodwill of health-care providers. However...

Table of contents

• Cover
• Half Title
• Series
• Title
• Copyright
• Dedication
• Contents
• List of Figures
• Foreword
• Acknowledgments
• 1 Introduction: Medicine, Mistakes, and Moral Evaluation
• Part I Questions of Justice
• Part II Communication and Risk
• Part III Vulnerable Populations
• Part IV Learning From Error
• List of Contributors
• Index