A Public Health Approach to Reducing Error: Title and subTitle BreakMedical Malpractice as a Barrier

The mortality resulting from medical errors each year in the United States is estimated to be between 44,000 and 98,000—accounting for more deaths than from motor vehicle crashes, breast cancer, or acquired immunodeficiency syndrome.^{1 - 3} Medically induced injuries and deaths not only represent a major public health problem, but also incur economic costs and loss of trust in the medical profession. The Institute of Medicine has initiated a project on Quality of Health Care in America to redesign the health care delivery system, align incentives, and transform information technology to dramatically improve patient safety.¹ In response, President Clinton proposed a national error prevention system that includes mandatory reporting of all medical errors that result in death or serious injury.⁴ As Mohr⁵ explains in this issue of THE JOURNAL, these reforms will take place within a deep historical and contemporary backdrop of medical malpractice litigation. A key issue is whether and to what extent medical malpractice creates barriers to quality improvement and, if so, what kinds of tort reforms could be helpful.

The quality of health care is, by many accounts, a serious problem.⁶ Research has demonstrated that physicians overuse health care services by ordering unnecessary interventions that are costly and place patients at risk^{7 - 8} ; underuse services by failing to provide standard care that would produce favorable outcomes⁹ ; and misuse services by devising the wrong treatment plan or improperly executing the correct plan.¹⁰ The quality of care for racial minorities and uninsured patients presents a particularly important problem in many hospitals.¹¹

A complex public and private system for improving quality is in place, but considerable uncertainty exists about whether it works. From a legal perspective, government directly and indirectly (through the tort system) regulates the health care system. From a medical perspective, an ethos of professionalism and a system of self-regulation exist. From a consumer perspective, choice among health care professionals and health plans, together with market forces, can influence quality. For example, the publication of performance measures, or report cards, provides incentives to improve quality because poor outcomes may result in government sanctions, loss of accreditation, and consumer dissatisfaction.¹²

Despite all of these efforts, the health care system has not matched the safety record attained in other industries, leading policymakers to consider systemic approaches to quality improvement. The lesson learned from other high-risk industries is that quality improvement requires designing processes and systems to prevent human error rather than focus on blame. For example, the aviation¹³ and motor vehicle¹⁴ industries have dramatically reduced injuries and deaths primarily by improving product design and personnel training, as well as by identifying and learning from errors.¹⁵ Using the model from other industries, the most innovative and modern approaches to quality improvement in health care call for a comprehensive strategy including (1) a national agency to provide leadership and research; (2) mandatory and voluntary reporting of medical errors; and (3) safety systems within health care organizations.¹

Ostensibly, medical malpractice litigation seeks the same objective—higher quality of care. A primary function, or goal, of tort law is deterrence of substandard medical conduct to avoid unnecessary injury. Despite the apparent identity of interests, law and medicine, persistently and deeply, are seen to be in conflict. At the very least, convincing data exist demonstrating the inadequacy of the tort system both as a deterrent of substandard practice and as a fair method of patient compensation. Many injuries caused by medical error are never litigated or are litigated unsuccessfully. At the same time, in a significant percentage of litigated cases, there is no demonstrable negligence or no medically induced injury.¹⁶ Furthermore, in litigated cases, the severity of the patient's disability, not the occurrence of an adverse event due to negligence, best predicts the payment of claims to plaintiffs.¹⁷

Physicians perceive medical malpractice litigation not only as inaccurate, but also as a barrier to quality improvement. Fear of litigation induces physicians to practice defensively and, more important, to maintain secrecy in the face of error. Details about medical error are highly attractive to plaintiffs' attorneys, who can use these data to strengthen their cases against physicians and health care organizations. As a result, adverse health care events are thought to be considerably underreported, which seriously undermines public health efforts to learn from and correct medical error. An obvious reform would be to promote greater legal safeguards of privacy in reporting and surveillance systems. One possibility might be to have a "panel of peers" to review the data and develop and implement an intervention for error prevention, with disciplinary measures if necessary. This kind of reform is worth pursuing despite the legitimate public interest in being fully informed about risks in the health care system.

Legal safeguards for preventing discovery of adverse event data currently exist but are highly imperfect. The most important of these safeguards are peer review privileges, enacted in every state except New Jersey. However, these statutes protect data only within limited settings (eg, peer review committee deliberations) and under narrow circumstances. Systems or collaborations outside the hospital or that cross state lines are often excluded from privacy safeguards. Peer review privileges are thought to be so variable and inadequate that they fail to reassure health care professionals and organizations that data will not be used in litigation against them. The Medicare Payment Advisory Commission recently recommended that Congress enact legislation to afford privacy protections to data related to patient safety and quality improvement that are collected by health care organizations for internal use or shared with others solely for that purpose.¹⁸ Models for this kind of approach can be found in existing statutes protecting quality assurance data in certain national (eg, National Practitioner Data Bank) and state (eg, New York) reporting and tracking systems.

Beyond limited proposals to impede plaintiffs' discovery of quality assurance data, several tort and insurance reform measures have been publically debated. The most prominent among these proposals are capitations on damages, which have been enacted in some states. While this approach does not eliminate liability, it would decrease fears of inordinate damage awards. More ambitious proposals include enterprise liability, which would transfer liability from health care professionals to responsible organizations.^{19 - 20} Alternatively, some proponents of reform have proposed no-fault compensation for medical injuries, similar to workers' compensation laws.²¹ These reform proposals are intended to create a legal environment more conducive to quality improvement, but they face substantial political opposition by avoiding physician responsibility and accountability for medical error.

The lessons of history, as Mohr reminds us, militate strongly against the feasibility of fundamental tort reform. The medical factors that have perpetuated medical malpractice litigation not only continue but are in the public interest: scientific innovation, uniform standards, and liability insurance. It also appears unlikely that the legal factors (eg, contingent fees, citizen juries, and tort pleadings) will disappear from the US landscape.

Quality assurance in the health care system is an important public health objective.²² A public health approach requires health care professionals and organizations to participate in a coordinated effort to understand the nature and extent of medically induced injuries through a sophisticated surveillance system and to establish systematic prevention strategies. It is imperative, however, that legal impediments to reporting, surveillance, and prevention are recognized and resolved before a truly safe health care system can become a reality.²³