Enterprise Dispute Resolution:Full Disclosure and Early Offer Policies in the Event of an Indisputable Medical Error

Abstract

The 1999 release of “To Err is Human: Building a Safer Health System” by the Institute of Medicine (IOM) rocked the healthcare arena, uncovering the massive amounts of medical errors prevalent in our healthcare system. Attributing as many as 98,000 deaths each year to “preventable medical errors,” the IOM report forced providers to confront their roles in causing patient harm. If the Center for Disease Control were to list “preventable medical error” as a cause of death, these staggering numbers would make it the sixth leading cause of death in the United States, before Diabetes or Alzheimer’s disease. The medical community was on notice. Lack of patient safety was its own cancer, a scourge on the providers’ oath to “do no harm.” The ethical mandate to champion patient safety was clear, and ensuring transparency in healthcare delivery during all stages of care was the only way to achieve the goal. The more progressive entities quickly realized that, in the aftermath of medical error, they would have to work with patients, rather than against them, to minimize harm. The movement toward full disclosure and transparency gained momentum.

Despite the spotlight the IOM report shined on this dark side of medicine, the efforts to reduce preventable errors and increase patient safety are failing. In 1999, the number of deaths attributable to medical error was equivalent to the number of deaths if a commercial jetliner crashed on American soil every day. Paul Levy, former CEO of Boston’s Beth Israel Deaconess Medical Center, contextualized by stating, "I don't think that crashing a 727 jet every day and killing everybody aboard is a good standard of care in U.S. hospitals. If that happened in aviation, they would shut the airlines down."

Today, over a decade after the perilous report, patients continue to suffer lethal medication errors and erroneous care leading to avoidable medical harm. A 2010 study by the Department of Health and Human Services – Office of Inspector General revealed that in the course of one year, one in seven Medicare beneficiaries, at least 134,000 people, suffered at least one adverse event upon admission, with many of these events considered "clearly or likely preventable." In November 2010, the New England Journal of Medicine followed suit and published the disturbing results of a five-year study of North Carolina hospitals which revealed that, between 2002 and 2007, efforts to make hospitals safer in response to the IOM report had failed. One of the most comprehensive efforts to collect patient safety data since the 1999 IOM report, this study exposed the staggering truth that 25.1 incidences of harm occurred for every 100 hospital admissions, translating to 25% of all admitted patients suffering a preventable harm. 2.9 percent of these cases resulted in permanent injury, such as brain damage; slightly more than 8 percent resulted in life-threatening illnesses; and, 2.4 percent resulted in patient death.

The basic “fight or flight” instinct is not only expected, but usually, an acceptable human response to adverse circumstances. However, in the instance of a provider-caused medical error, the analogous “deny or defend” response employed by most medical entities forces patients to file suit, leading to prolonged litigation, often for the simple purpose of obtaining information as to how and why the error occurred. As set forth more fully below, litigation also causes unnecessary suffering for survivors as well as the providers. Even more dangerous, the “deny and defend” approach discourages providers from disclosing the cause or source of the error, essentially precluding the ability to implement policies and procedures to prevent recurrence of the error.

This paper argues the economic and ethical benefits of full disclosure, early offer, and apology in the event of a medical error indisputably caused by a provider. While formal implementation of full disclosure and early offer programs methodically vary by facility, the overall advantages of increasing transparency in medical care and its attendant communication are irrefutable. Section I summarizes the protections of the Patient Safety and Quality Improvement Act of 2005 (PSQIA) and how they provide a basis for many of the successful full disclosure and early offer programs currently employed by healthcare systems. Section II describes the practical application of full disclosure as a method of avoiding malpractice litigation in cases of indisputable error. It details the devastating story of Mary White, a mother of two who, although a victim of egregious medical error, opted not to file suit after providers were forthcoming and apologetic for their errors. Section III examines the root of malpractice litigation, including why patients sue, as well as the ineffectiveness of the “deny and defend” approach usually invoked by the providers who defend malpractice from behind a shield fortified by a “culture of silence.” Section IV discusses the importance of transparency and full disclosure throughout the course of medical care beginning with informed consent, and not just after the occurrence of an adverse event. This section also illustrates the benefits a full disclosure policy lends to providers, enabling them to exchange crucial information without the fear of negative professional or personal backlash. Section V reveals a deterrent to apologize that is common to the vast majority of providers. It is contrasted with the positive effect of a sincere apology, both on the provider as well as the victim of medical negligence. Section VI provides a synopsis of highly successful full disclosure and early offer programs currently utilized at the University of Michigan, University of Illinois, and Stanford University medical centers. Section VII describes the recent law enacted in Massachusetts, the first of its kind, which legally mandates the “Disclosure, Apology, and Offer’ approach as the primary method of resolving medical malpractice claims. This paper concludes with the determination that a well-designed and well-managed full disclosure, apology, and early offer program results in economical and ethical benefits to providers, patients, and the healthcare landscape as a whole.