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Abstract:
Changes in malpractice law remain an important goal of health care reform. Many state and federal legislators continue to call for measures that would limit the ability of injured patients to sue. There is also growing interest in alternatives to fault-based litigation. As legislators consider no-fault proposals, they can look to Florida's experience with the Neurological Injury Compensation Association (NICA), which for the past four years has been providing no-fault compensation for injured newborns. NICA provides some insights Ito the ways in which claims are generated, the nature of risk spreading, and the financial viability of a no-fault model.

malpractice law, no-fault compensation

Abstract:
The rhetoric of malpractice reform is at fever pitch, but political advocacy does not necessarily reflect grassroots opinion. To determine whether the ongoing liability crisis has significantly reduced physicians' professional satisfaction, we surveyed specialist physicians in Pennsylvania. We find widespread discontent among physicians practicing in high-liability environments, which seems to be compounded by other financial and administrative pressures. Opinion alone should not determine public policy, but physicians' perceptions matter for two reasons. First, perceptions influence behavior with respect to practice environment and clinical decision-making. Second, perceptions influence the physician-patient relationship and the interpersonal quality of care.

malpractice, satisfaction, liability, physician, insurance

Abstract:
Pennsylvania, like many states around the country, is in the throes of a "tort crisis." The cost of professional liability insurance for physicians and hospitals is escalating rapidly, as its availability shrinks. Many hospitals are poorly situated to bear these rising costs, especially in an environment of flat reimbursement rates and poor investment returns. This report examines the impact of the liability crisis on Pennsylvania hospitals and the strategies being used to weather the storm, including alternative risk financing and closer ties between hospitals and affiliated physicians. It concludes by connecting these trends to larger medical malpractice policy issues.

medical malpractice, hospitals, liability, insurance

Abstract:
Responsibility for policing the integrity of research funded by the Public Health Service falls primarily on the academic institutions at which researchers are based. Although the federal Office of Research Integrity exercises some oversight over institutions, it affords them wide latitude to determine their own processes for investigating allegations of misconduct. Consequently, institutional policies and procedures vary widely with respect to the due process protections afforded to accused researchers. Institutions commonly fail to provide meaningful opportunities for scientists to respond to allegations at an early stage. This article reviews the history of federal regulation of research misconduct and suggests that a more optimal balance between detecting fraud and protecting the rights of the accused would be achieved if the government required a greater degree of uniformity in the procedural safeguards guaranteed to researchers in institutional misconduct investigations.

research, fraud, misconduct, integrity, scientific

Abstract:
In the wake of recent revelations of serious injury to human subjects in research studies at major academic medical centers, lawsuits against investigators, institutional review boards (IRBs), and academic institutions are on the rise. This article tracks trends in litigation over research-related injuries, including (1) diversification of the types of legal claims alleged; (2) expansion in the number and types of parties named as defendants; and (3) use of class-action techniques. The authors argue that further growth of this litigation is likely, and that the litigation can be expected to have a chilling effect on the work of IRBs.

human subjects, research, clinical trials, litigation, tort

Abstract:
A major medical malpractice crisis is unfolding in the United States today. In the last two years, professional liability insurance premiums have increased dramatically for physicians in high-risk specialties such as obstetrics, emergency medicine, general surgery, surgical subspecialties, and radiology in states across the country. Many states have seen the departure of insurance carriers that had held very substantial market shares, leaving thousands of physicians scrambling to find alternative coverage. This article briefly summarizes the leading hypotheses about the drivers of the crisis, examines the impacts on providers and patient access to care, and reviews the main policy solutions proposed by state and federal governments.

Abstract:
The Leapfrog Group, a consortium of large employers, aims to use its collective purchasing power to motivate hospitals to implement particular measures designed to improve patient safety and the quality of care. While these criteria are meant to be purely aspirational, and while Leapfrog's effort is praiseworthy, we caution that the articulation of these standards of care may have unintended legal consequences. Efforts by aggressive medical malpractice attorneys could rapidly transform Leapfrog's standards from marketplace advantages for compliant hospitals to performance expectations required by law. This undesirable potential outcome compounds the importance of selecting these standards with the utmost care.

Abstract:
New patient safety standards from the Joint Commission on Accreditation of Healthcare Organizations that require hospitals to disclose to patients all unexpected outcomes of care took effect on July 1, 2001. We surveyed risk managers at a nationally representative sample of hospitals to determine current disclosure practices. The vast majority of respondents reported that their hospital's practice was to disclose harm at least some of the time; 36% had board-approved policies and 44% were in the process of developing policies at the time of our survey in early 2002. Although more than one half (65%) of respondents reported that they would always disclose a death or serious injury, when presented with actual clinical scenarios respondents were significantly less likely to disclose preventable than non-preventable harms of comparable severity. Multivariate analysis showed that reluctance to disclose preventable harms was twice as likely to occur at hospitals where there were significant concerns about the malpractice implications of disclosure.

Abstract:
Health care providers' incentives to participate in quality improvement and medical error reduction initiatives hinge on the degree to which they internalize the costs associated with hospital adverse events. The medical malpractice system potentially creates a "business case for quality" by providing a mechanism to force providers to absorb those costs. However, little is known about the effectiveness of malpractice litigation in deterring medical negligence. In this Article, we review the available evidence about its deterrent effect, including information from studies we have conducted of medical injury and malpractice litigation in New York, Utah and Colorado. We find some limited evidence of deterrence, but conclude that overall the evidence is thin. We review possible explanations for the weakness of the deterrent signal, including insurance effects, the poor degree of fit between who is injured by medical negligence and who sues, and the problem of cost-externalization. We then suggest a series of tort reforms that could focus deterrence and create incentives sturdy enough to improve quality. We advocate a shift to a system emphasizing greater enterprise liability and characterized by three features: channeling, experience rating, and limited no-fault compensation for preventable adverse events. We conclude that a reformed liability system could play an important role in making a business case for quality and safety in health care.

Abstract:
We now stand at the intersection of three major trends in American health policy: the dominance of managed care in health-care delivery; concerns about the impact of financial incentives on the quality of managed care, expressed in particular through litigation against managed care companies; and a renewed interest in medical "error" reduction at the system level. Managed care incentives are part of the system of health care. Financial influence on physicians affect behavior and could presumably increase the occurrence of errors. Lawsuits against managed care organizations should lead to changes in the system of incentives, and hence be one place where error reduction and litigation can act in concert. Two recent cases from the Supreme Court of Illinois demonstrate that when courts engage in "systems-think," increased managed care liability is likely to result. This leaves managed care organizations with the difficult choice of employing quality-enhancing management techniques or sounding the retreat from managed care.

Abstract:
In the 1990s more than 41,000 patients underwent high-dose chemotherapy plus autologous bone marrow transplant (HDC-ABMT) for breast cancer, despite a paucity of clinical evidence of its efficacy. Most health plans reluctantly agreed to cover the treatment in response to intensive political lobbying and the threat of litigation. The results of five recent major randomized trials showed that HDC-ABMT offers no advantage over standard-dose treatment for breast cancer. Our experience with HDC-ABMT coverage cautions against allowing politics to overwhelm science in the area of evaluating experimental procedures, and against relying on the courts as a means of resolving disagreements about coverage of these interventions.

Abstract:
From 1995 to 1998, we conducted an empirical research project in Utah and Colorado that was designed to estimate the burden of medical injury and the performance of the medical malpractice systems in those states. Our aim was to test the results of a similar project, the Harvard Medical Practice Study, conducted a decade earlier in New York. Part I of this Article recaps the intellectual and methodological heritage of the Utah-Colorado Medical Practice Study (UCMPS). Part II describes important changes in the health care system and peculiarities of the New York study that made repetition of a large-scale study of iatrogenic injury worthwhile. Part III describes the origins of the UCMPS itself. Part IV outlines methods and results from each of the four main areas of analysis that comprised the study: (1) incidence of medical injury; (2) malpractice claiming behavior; (3) the economic consequences of medical injury; and (4) the feasibility of alternative approaches to compensation. In conclusion, we discuss implications of the findings for health care policy.

Abstract:
Florida's Birth-Related Neurological Injury Compensation Plan (NICA) is the most ambitious experiment with no-fault compensation for medical injury yet undertaken in the United States. As NICA enters its second decade of operation, maintaining the scheme's jurisdictional integrity has emerged as a key challenge for policymakers in Florida. We explore the relationship that has emerged between NICA and the tort system as competing avenues for families to obtain compensation for severe birth-related neurological injury. By linking NICA claims data with data on malpractice claims filed in Florida, we found a lively persistence of "bad baby" litigation despite NICA's implementation. Many families pursued claims in both fora. An explanation for these results can be traced to key features of the Plan's design?primarily, the way in which "exclusive" jurisdiction over injuries is determined and the restrictive nature of the compensation criteria used. Our findings may help efforts to consolidate NICA's role in injury compensation and inform future design of alternative compensation systems.

Abstract:
Many new methods for measuring the quality of health care have been devised since 1970. For the past ten years, the health care field has been struggling to integrate industrial models into its quality improvement systems. In order to judge whether regulation has evolved in tandem with these developments, three critical questions are examined: Is regulation improving the quality of health care? Are regulators integrating the tools of quality research into their oversight activities? Is there a way to combine continuous quality improvement (CQI) and modern methods of quality measurement into a new regulatory format? An exploration of these questions produces relatively little evidence that regulation has moved in the recommended direction, although there are some encouraging signs that regulators are becoming more responsive to the issues.