We live in an anxious world, riddled with unpredictable threats to our safety and unexpected hatreds directed toward us. It is easy to obsess on the terrors around us, about which we can do little, and lose perspective on the real and sometimes devastating risks that we encounter in our daily lives. These everyday risks need to be regularly revisited — to remind ourselves that they can be reduced with the application of sharp minds, careful scholarship, and political will.

Medical errors in the American health-care system are just such a problem. The risk of death or serious injury at the hands of the American health-care system is not trivial, as we have learned over the past few years as the health-care establishment has acknowledged the level of iatrogenic injury in the system. If, as the Institute of Medicine reported in To Err Is Human, as many as 100,000 people every year are dying in hospitals, clinics, and doctors’ offices as the result of actions or omissions that could have been avoided, then this is a social problem of great magnitude and one that the law must try to correct.

Following the seemingly endless debate over managed care liability, I cannot suppress thoughts of Yeats’s poem, “The Second Coming.” It is not the wellknown phrase, “Things fall apart; the centre cannot hold,” that comes to mind; although that could describe the feeling of a health-care system unraveling. The poem’s depiction of lost innocence — “The best lack all conviction, while the worst/Are full of passionate intensity” — does not allude to the legislature, the industry, the public, or the medical or legal profession. What resonates is the poem’s evocation of humanity’s cyclical history of expectation and disappointment, with ideas as grand as justice and occupations as pedestrian as managed care. Writing in 1919, Yeats described the end of an era with images of war’s destructive forces. The poem expresses a universal desire for some miraculous rebirth or resolution of all problems: “Surely some revelation is at hand.” But instead, the brutish Sphinx-like creature emerges, possibly the Antichrist. New gods displace old gods in the cycle of civilization, and man must muddle on.

The transformation of health-care delivery from fee-for-service medicine to managed care represents a fundamental philosophical shift away from the prevailing medical ethos that the needs of the individual patient take precedence over competing social values, such as reducing health-care costs. In managed care, financial incentives to reduce health-care utilization may result in denying an individual’s claim for medical services.

Litigation challenging managed care’s resource allocation decisions often presents the need to resolve conflicting social policy goals, such as the tension between an individual patient’s access to health care and a managed care organization’s (MCO’s) need to restrain costs. Conflicts may arise when a patient’s desire for unconstrained health care clashes with a provider’s and an insurer’s cost containment strategies. In turn, cost containment strategies may raise questions about restrictions on physician autonomy and conflicts among stakeholders for control over resource allocation decisions.

Three major trends in American health policy are intersecting in a fascinating way. First, managed care has grown to become the most dominant form of health-care delivery, leading to reductions in health-care costs as insurers are able to influence health-care providers with financial incentives. Second, the present growth of managed care has slowed, almost to a standstill, largely on account of consumers questioning what effects these financial incentives are having on the care of patients — questioning that has been expressed in particular through lawsuits against managed care companies.

Third, we are experiencing a renewed interest in the existence of medical error and how it may be reduced as a result of the Institute of Medicine’s (IOM) report, To Err Is Human: Building a Safer Health System. The most important aspect of this renaissance in error reduction has been its emphasis on health care as a system that can be made better through system-oriented change. The most frustrating aspect is that the IOM did not endorse change in malpractice liability, which consistently puts the impetus for reducing medical error on the individual provider rather than the system as a whole.

The Institute of Medicine (IOM) has returned the problem of medical error to the top of the health-care agenda. Its report that 44,000 to 98,000 patients die each year as a result of medical errors in American hospitals has renewed scholarly interest in health system quality control. In To Err Is Human, the IOM provides a vivid picture of a health-care system riven with serious quality problems. It calls for systems-based error-reduction methods borrowed from other high-risk industries and forcefully argues against the traditional tendency to assign accountability primarily to individual physicians. Most errors, the IOM argues, can be successfully addressed by engineering systemic fail-safe protections against the inevitable failings of human actors.

There have always been medical standards of care in the American health-care sector. However, never before have they been so deeply incorporated in the delivery of health care as they are today. With the increased delivery of care through integrated delivery systems, as well as the development of the computerized patient record, medical standards of care are now used in innovative ways by providers and health plans in delivering health care to individual patients. There is great potential for even more innovative uses of medical standards of care in the future.

This article first presents a taxonomy of the medical standards of care that are involved in health-care delivery today Next, the article traces the historical evolution of medical standards of care since the early 1980s. Included in this discussion are the origins of the standard-setting movement as well as the developments that led to the way standards of care are currently used by large institutional providers and managed care plans to improve the quality of their health-care services. The article concludes with a brief analysis of the key legal issues that affect how standards of care can be used to improve the health care of patients.

Tort claims have been studied for various reasons. Several studies have found that most tort claims are not related to negligent adverse events and most negligent adverse events do not result in tort claims. Several studies have examined the disposition of tort claims to understand the likelihood of payment once a claim has been made. Still others have proposed that tort-claims trend analysis may help administrators target their quality-improvement efforts and identify problems with quality that would not otherwise be captured.

In this article, we conduct a tort-claims analysis to explore areas for quality improvement, specifically for patient safety, in the Veterans Health Administration (VHA). Patient safety is an increasingly highlighted aspect of health-care delivery. Failure to assure patient safety can result in bad clinical outcomes, additional costs of care, and a negative organizational image. Filing a tort claim is one way for an individual to express concern about an organization. For our analysis, we draw from resolved tort claims in the Veterans Health Administration from fiscal years 1989 to 2000.

Patient safety has assumed a prominent role on the policy agenda since the Institute of Medicine report To Err Is Human was released in November 1999. The report maintained that medical error is the predominant mechanism by which patients in the United States and around the world are injured. This finding, along with the report’s recommendation for a “systems” approach to reducing medical error, provided an extremely important insight into the operation of our medical delivery system. Clearly, while advances in medical technology, diagnostic techniques, and knowledge provide the foundation for saving lives, medical error has resulted in their loss. However, recognition that medical error is a primary cause of these avoidable patient injuries and deaths is a key one and may result in improvements within our system of health-care delivery as well as minimization of the emotional and financial toll that iatrogenic injury causes.

Too many patients are injured in the course of care. Clinicians may mistakenly cause new harm to a patient or fail to take established steps to improve the presenting condition. Medical institutions within which they work may lack mechanisms to reduce errors or prevent them from harming patients. Many, perhaps even most, injuries are preventable, probably numbering in the hundreds of thousands a year for hospital care alone. Long ignored by medical practitioners and health-care payers and little appreciated by the public, the problem of medical injury is finally receiving high-level policy attention. Much credit goes to the Institute of Medicine (IOM) for its landmark report of November 1999, which marshaled the evidence about medical injuries and highlighted new approaches to systematic improvement of safety within systems of care.

Health-care provider liability has again taken center stage in American political debate, but with an ironic twist. In the seventies, physicians wanted tort reform, but they measured such reform solely by a reduction in both the risk of being sued and the size of any judgment a plaintiff could win. Malpractice reforms in many states in the seventies therefore capped damages, reduced contingency awards to lawyers, and restricted other tort rules to limit plaintiff success. Today physicians are conflicted. They want an increase in liability exposure — not for themselves, but for managed care plans. We have therefore ended up with a series of overlapping debates, with the same debaters taking contradictory positions. Should managed care organizations—until now protected by ERISA preemption from liability—be liable? Physicians say yes. But should physicians be protected from the threat of suit, which they argue acts as an in terrorem device that drives disclosure of medical errors into hiding?

On July 2, 2001, a medical milestone was reached when Robert Tools received a total artificial heart implant at Jewish Hospital in Louisville, Kentucky. Tools was implanted with an AbioCor artificial heart, one of several brands of new-generation artificial hearts that has been approved by the U.S. Food and Drug Administration (FDA) for clinical trial. The AbioCor heart was developed by Abiomed of Danvers, Massachusetts.

Following the surgery, physicians were guardedly enthusiastic about the device and optimistic about the patient’s future. Tools, 59, has had a history of numerous heart attacks and by-pass surgery, as well as diabetes and kidney problems. He met the requirements of the AbioCor protocol because he was not a candidate for transplant, death was otherwise probable within thirty days, and other interventions were deemed ineffective. Researchers hope that strengthening his heart function will result in increased function of his other vital organs, thus prolonging the patient's life and increasing his energy. But because the device is experimental, nothing can be promised.