More hippocrates, less hypocrisy: "early offers" as a means of implementing the Institute of Medicine's recommendations on malpractice law.

• Author: O'Connell, Jeffrey

1. INTRODUCTION

   According to disturbing, if admittedly controversial, estimates found in To Err is Human: Building a Safer Health System, a 1999 report published by the Institute of Medicine [hereinafter "IOM"], between 44,000 and 98,000 Americans die each year due to preventable medical errors. (3) Under these figures, more Americans die in a given year as a result of medical errors than from motor vehicle accidents (43,458), breast cancer (42,297) or AIDS (16,516). (4) Total national costs (lost income, lost household production, disability and health care costs) of medical errors that result in injury are estimated to be between $17 billion and $29 billion, of which health care costs represent over one-half. (5) The increased hospital costs of preventable medication-related errors to patients alone are estimated to be about $2 billion for the nation as a whole. (6)

   As William C. Richardson, chairman of the panel that conducted the IOM study, aptly comments in citing the Hippocratic Oath, "These stunningly high rates of medical errors--resulting in deaths, permanent disability and unnecessary suffering--are simply unacceptable in a medical system that promises first to `do no harm.'" (7) Significantly, the IOM contends that most medical errors are not caused by the carelessness of individual physicians, nurses, or other hospital personnel; rather, they are the result of the cumulative opportunities for human error that inevitably arise in today's complex medical system. (8) One area that clearly shows the systemic root of medical error involves medication errors. For example, pharmacists often have difficulty deciphering the illegible handwriting of doctors who prescribe drugs. (9) Also, many new drugs have similar names, causing much confusion for doctors, nurses, and patients. (10) Indeed, some 7,000 hospital patients died in 1993 due to medication-related errors alone, more than the number of Americans who die from workplace injuries in an average year. (11)

   The IOM report condemns current systems of dealing with medical mistakes, which include a combination of peer reviews, various state and federal regulations and sanctions, evaluations by private accrediting bodies, and, lastly, malpractice lawsuits. (12) The report goes on to make several recommendations in an effort to lessen these forbiddingly high rates of medical error. (13) Most salient from a tort law perspective, the IOM calls for the creation of two distinct reporting systems. (14) First, the IOM recommends the establishment of a federal mandatory reporting system for cases where medical error has led to serious injury or death. (15) Medical errors identified through this mandatory reporting system would be open to the public and unprotected by confidentiality rules. (16) Information from this database would thus be open to discovery in a lawsuit. The IOM concedes that liability in tort "serves a legitimate role in holding people responsible for their actions." (17)

   The report also suggests that minor medical errors that have not resulted in serious injury or death be collected in a confidential database that would be unavailable to the public. (18) By reducing health care providers' risk of medical malpractice lawsuits through the confidentiality of this reporting system, the IOM hopes to encourage doctors, nurses, and hospital administrators to be more open about minor medical mistakes that have not led to serious adverse events, thereby giving the medical community greater opportunities to learn from their mistakes and prevent future harm to patients. (19)

   To remove the fear of personal liability from individual health care workers and eliminate the incentive to hide errors rather than report them, the IOM acknowledges that tort reform of some sort is also needed. (20) Since the IOM calls for shifting attention away from the faults of individual care providers to the defects of the system itself, the current tort system's "blame culture" is itself blamed by the IOM for providing an impediment to improving the safety of patients by deterring physicians from reporting their own errors in the first place. However, the IOM's To Err is Human does not offer an extensive account of just what tort reform scheme should be pursued. In what follows, the Early Offers plan, created by the first-named author, is urged as particularly well-suited to address the problem of medical errors dealt with in To Err is Human. `Early Offers' is not only designed to promote the reporting of medical errors by reducing the level of fear and pain associated with current medical malpractice law, but at the same time to allow victims of medical error to receive compensation earlier and easier. In so doing, Early Offers promotes a better medical and legal culture by rendering the health care and medical malpractice systems more Hippocratic--and less hypocritical.

2. THE IOM STUDY

   Before entering into a legal discussion concerning the benefits of Early Offers in the area of medical malpractice law, this section offers a more detailed account of the IOM study. The need for reform will grow more apparent as more is revealed about the complexity of safety problems facing the nation's health care providers and their patients.

   The IOM, a branch of the National Academy of Sciences, is a congressionally chartered, private, nonprofit society of distinguished scholars engaged in scientific research. (21) Specifically, the IOM acts as an advisor to the federal government, identifying issues of medical care, research, and education. (22) Recommendations by the IOM traditionally carry substantial political weight in Washington, D.C. (23) Indeed, within two weeks of the release of To Err Is Human on November 29, 1999, Congress began relevant hearings and President Clinton ordered a government-wide study of the feasibility of implementing the report's recommendations. (24)

   The IOM study was released as the first of a series of reports issued with the aim of achieving a "threshold improvement" in health care quality over the next ten years. (25) The Committee on Quality of Health Care in America, a subdivision of the IOM that conducted the study on medical error, consisted of various professionals from the medical, business, and academic communities. (26) A sampling of those who sat on the panel include William C. Richardson, President and CEO of the W.K. Kellogg Foundation, Dr. Lucian Leape of the Harvard School of Public Health, and Dr. Mark Chassin of the Mount Sinai School of Medicine. (27)

   As outlined in the opening pages of To Err is Human, the report seeks to address issues related to patient safety, a subset of overall quality-related concerns, and lays out a national agenda for reducing errors in health care and improving patient safety. (28) It should be noted that the IOM's report only reflects empirical data concerning medical error affecting hospital patients. (29) Therefore, with more than half of all surgeries today occurring on an outpatient basis, the report's scope can be seen as somewhat limited. (30) In making its recommendations, the IOM panel drew largely upon research gathered in two studies: (1) the Harvard Medical Practice Study, a groundbreaking report released in 1991 in which the subject of medical error was systematically examined through information garnered from a 1984 hospital admissions database in New York state; and (2) a 1992 study of Colorado and Utah hospitals using the same methods as the 1991 Harvard study. (31) Thus, many of the statistics mentioned in To Err is Human are extrapolated from prior research conducted in New York, Colorado and Utah.

   "Error" is defined by the IOM panel as "the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim." (32) An "adverse event" is an injury caused by medical mismanagement rather than the underlying condition of the patient. (33) An adverse event attributable to error is a "preventable adverse event." (34) While "adverse events" result from medical mismanagement, not all are preventable. An example drawn from To Err is Human helps to illustrate this point. If a patient has surgery and dies from pneumonia occurring after the operation, it is an adverse event. (35) If analysis of the case later reveals that the patient got pneumonia because of poor hand washing or instrument cleaning techniques by the staff, the adverse event was "preventable," i.e. attributable to error. (36) However, an investigation of the incident may conclude that no error occurred, and that the patient's system simply reacted poorly to the surgery, indicating that the pneumonia was not a "preventable adverse event" and was attributable rather to the idiosyncratic response of the patient himself. (37)

   According to the IOM, the rate of preventable adverse events in the nation's hospital systems is truly daunting. The data gleaned from the 1984 Harvard study in New York indicate that as many as 98,000 patients may perish each year in American hospitals as a result of preventable adverse events. (38) This estimate renders medical error the fifth leading cause of death in the U.S., above such other scourges as pneumonia, diabetes and kidney disease. (39) Even by the more conservative estimate of 44,000 deaths per year, the amount generalized from the Colorado/Utah study, medical error would still rank as the eighth single leading cause of death in this country. (40) Other striking statistics that leap out at the reader, in addition to those recited at the onset of this paper, include the following:

   * The costs of medical adverse events are recorded as being higher than the direct and indirect costs of caring for people with HIV and AIDS; (41)

   * Preventable medication-related adverse errors are dramatically rising: among medication-related outpatient deaths, there was nearly 8.5% increase in frequency between 1983 and 1993; amongst medication-related deaths occurring in hospitals...