Issues surrounding professional liability in medicine have been present for many years, but only recently has medical malpractice, because of the high cost of liability insurance, become a major focus for health care providers. During this time interval, there have been three periods labeled as “malpractice crises.” The first crisis appeared in the early to mid 1970s. During this time, the frequency and severity of claims rose dramatically while the coffers of the insurance companies were depleted by the recession following the Arab oil embargo. Many insurance companies stopped writing policies, leaving many physicians without coverage. Tort reform started to occur with MICRA (California’s Medical Injury Compensation Reform Act), becoming the poster child and the sole single success continuously cited by those pushing tort reform. Medical societies started their own insurance carriers, and many states established joint underwriting associations and various funds to soften the financial blow to physicians. During that time and up to the current situation, minimal effort was made to address the underlying problems of preventable medical errors and an unsafe health care system.

The second crisis occurred in the mid 1980s. The key issue that time was the marked increase in liability insurance cost, not its availability. The rate of return for the insurance companies plummeted secondary to the marked decrease in interest rates. Occurrence policies transitioned to claims-made policies, with the physician responsible for large tails. This helped to keep physicians practicing in the same location, as it became prohibitively expensive to move to a different state. Other states adopted various tort reform measures, and eventually, the crisis abated. Unfortunately,
the issue of preventable medical errors and an unsafe health care system again was not addressed.

The current crisis is different because of the inability of the physician or institution to pass on the increased costs of liability insurance and the major emphasis of the public, industry, and government on improving patient safety and preventing medical errors. The crisis is most felt by specialties such as obstetrics, orthopedics, neurosurgery, and radiology. Liability insurance is available, but it is primarily an economic issue, as most physicians can obtain coverage but at a premium that makes it less likely that they can continue their current practice.

During the last 20 years, health care spending has increased dramatically as technology has improved and patient expectations have risen. This has resulted in a proliferation of avoidable errors with increased costs to care for those who suffer harm. The end result is a linear increase in the cost of professional liability insurance and the costs associated with litigation.

This problem is especially evident in the practice of obstetrics because of the large number of patient interactions that occur over a short time period, resulting in an increase in the number of adverse events or potential adverse events. It is important to understand that the definition of an adverse event is one that results in unintended harm to the patient that is not related to the underlying disease or clinical condition and is secondary to an act of commission or omission. Although serious adverse events are infrequent in a busy obstetric service, they do occur, are often preventable, may result in an injury, and have the potential to become a legal action. A recent publication revealed that 5% of obstetric patients experienced an adverse or potentially adverse event and that 87% of the problems were due to errors. The most common were system errors such as inadequate staff, physician, or operating room availability and lack of uniformity of care.

There is abundant misinformation cited by physicians about the malpractice arena such as number of frivolous claims, financial outcome of claims, and the rarity of medical errors. The physician is most happy if there are very few claims and all are dropped or won in court. The physician, the insurer, and the defense attorney desire secrecy, deny fault, try to place blame on someone else, and prolong the process, thus making it expensive for the plaintiff to continue.

Most physicians believe that frivolous litigation (claims with no scientific basis) are common and costly. In a review of 1,452 closed malpractice claims, 3% of the claims had no verifiable medical injury and 37% did not involve errors. The vast majority of these claims did not result in any compensation, while the majority that did involve error resulted in compensation. The obstetrician–gynecologist was most frequently sued followed by the general surgeon. Eighty percent of the claims involved injuries that caused significant disability or death. Payment occurred in the absence of injury in 0.4% of claims, payment in the absence of error in 10.0%, and no payment in the presence of error in 16.0%. The authors concluded that eliminating all claims that did not involve errors would decrease the direct costs by 13% to 16% and that most of these claims resulted in no payment. The malpractice system did well in compensating those patients who had legitimate claims, but 17% of claims in which an error occurred received no compensation. The overhead costs of the total system were extraordinary, with the plaintiffs only receiving 54% of total compensation paid. Other than preventing medical errors, the efforts of reform should be placed in improving the efficiency of the system in order to decrease the exorbitant overhead costs.

The current professional liability crisis has reawakened the interest in tort reform, a concept that has been discussed for over 30 years. At a conference on medical malpractice policy, it was observed that the political stakeholders on one side lobbied for adoption of a California MICRA-style tort reform to discourage lawsuits and limit recoveries, while the academic community was unanimous that traditional tort reform is an incomplete solution to a critical problem. The emphasis of most medical professional societies has been on seeking tort reform with the imposition of noneconomic damage caps and contingency fee limits. The purpose of tort reform has been on reducing liability for medical errors and not on error prevention. Both Studdert and colleagues and Kessler and associates have demonstrated that the pursuit of tort reform over the last 30 years has had minimal results, with little attention paid to improving the quality of medical care and the safety of the health care system. Also, the tort reform currently being pursued has not been linked to newer developments in evidence-based medicine or the increasing number of preventable medical errors. These contrary positions cannot be reconciled.

An attempt at federal tort reform, the HEALTH Act of 2003 (Help Efficient Accessible Low-cost Timely Health Care) has stalled in Congress several times and is unlikely to pass in the future. The name of the act is ironic, as health care is often not timely, clearly not efficient, and certainly not low cost. Nothing in the act addresses the issues of patient safety and preventable medical errors. If the federal government is truly committed to improving patient safety, it should mandate and assist in the funding of a national electronic health record. Patient safety and quality of care are adversely affected on a daily basis by the common occurrence of missing clinical information. A national electronic health record will immediately improve patient safety, dramatically increase efficiency, and decrease costs with the likelihood of a decrease in liability actions.

Tort reform supporters cite the passage in 1976 of MICRA in California with the resultant effect being that liability insurance rates have risen at a slower pace than those in other states. The noneconomic damage cap of $250,000 is important for tort reform but is unfair to injured patients, as it has not been adjusted for inflation since its passage.
The tort reform represented by MICRA is in reality an insurance reform act. Caps will have little effect on frivolous lawsuits, as the amount of money involved in these types of suits is usually below the cap. While the limits on attorney contingency fees may be the most important part of MICRA, this is one of the major blocks to passage of tort reform, as the majority of politicians who would vote at the national level are attorneys. The problem with any type of tort reform is that it is a back end approach. No evidence exists that it addresses the real issues: preventable medical errors, improved patient safety, full disclosure of all adverse events, and poor practitioners. These same issues have been present during all of the professional liability crises. The only rational solution to solving the professional liability crisis is to deal directly with the issues of patient safety and medical errors.

Patient safety must be the predominant theme in any discussion of liability issues. A recent study analyzed 4 months of medical care in a 40-bed medical unit of a major teaching hospital. Adverse events were experienced by 8% of patients, and 4% experienced near misses. Only 55% of adverse events, 34% of medical errors, and 31% of near misses were documented in the medical record. No hospital incident reports were filed in any of the events.

A university analysis of 90 closed claims in obstetrics–gynecology identified specific factors that may have contributed to adverse events in 78% of cases, with most having more than one factor. Communication problems existed in 31% of cases, clinical performance in 31%, diagnostic issues in 18%, and patient behavior in 14%. It is these types of issues that must be dealt with before any professional society or group of physicians can expect to see tort reform.

Five years after the Institute of Medicine report To Err Is Human, progress in the prevention of medical errors and improvements in patient safety has been slow to nonexistent. The rapid advances in medical technology and the increasing workload secondary to staff reductions have markedly elevated the number of preventable medical errors. An attempt by the Agency for Healthcare Research and Quality to determine a national estimate for the improvement in patient safety by using existing measures has demonstrated little to no improvement since 1999. The number of deaths that occur yearly in U.S. hospitals appears to have doubled since the 1999 Institute of Medicine report. While the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has attempted to improve patient safety, medical errors and deaths have continued to increase. The JCAHO review of hospitals with the threat of loss of accreditation produces transient compliance in addressing patient safety issues. Historically, after the review, the majority of hospitals return to “business as usual.”

It is difficult to evaluate any improvements in patient safety, as data are not available to yield a credible result. One reason that data are difficult to obtain is that the vast majority of incidents occurring in a hospital are actually not reported to any oversight body. Pronovost and coworkers have proposed two measures that can be captured with minimal bias: (a) how often are patients harmed, and (b) how often do clinicians provide appropriate interventions? Two other measures that are elusive to track are (a) have clinicians learned from their mistakes, and (b) how successful are clinicians and hospitals in creating a culture of safety?

A major change in the culture of medicine is required in order to improve patient safety and prevent medical errors. The assumptions that must be addressed to change the culture are that medicine is extremely complex but can be mastered by one person, perfection is an obtainable goal for the individual, physicians are fierce supporters of autonomy, the leadership of the physician cannot be questioned, and that full open disclosure of all medical errors will increase liability actions. Lessons learned from the aviation industry are that a complex system like medicine requires teamwork, the captain cannot be the master of all systems, any member of the team can challenge another when safety is involved, information obtained about adverse events or near misses can be used to improve the system to prevent future occurrences, and full open disclosure increases public trust. These lessons are directly applicable to medicine and must be used in order to improve patient safety and prevent medical errors.

The traditional way that most hospitals respond to patient safety issues is to develop a hospital policy to deal with a previous adverse event or system failure. It is rare that members of the medical staff are familiar with all the hospital policies that are in place. It is unusual for any type of system to be in place for implementation or follow-up of results of the policy. Hospitals continue to be reactive to patient safety issues and avoidable medical errors. It is obvious that only a proactive approach will ever change the current dangerous nature of the U.S. health care system.

The Institute for Healthcare Improvement (IHI) has recently announced its 5 Million Lives campaign, an attempt to protect patients from 5 million incidents of medical errors over a period of 24 months, ending December 9, 2008. This campaign follows the success of the 100,000 Lives campaign. In that campaign, there were 3,100 participating hospitals, and an estimated 122,000 inpatient deaths were prevented over 18 months following the six interventions recommended by the IHI. The six interventions implemented that had been proven to prevent avoidable deaths were (a) availability of rapid response teams, (b) evidence-based care for acute myocardial infarction, (c) prevention of adverse drug events, (d) prevention of central line infections, (e) prevention of surgical site infections, and (f) prevention of ventilator-associated pneumonia (Table 64.1). Currently, the IHI estimates that there are 40 to 50 incidents of harm that occur for every 100 hospital admissions. With 37 million hospital admissions each year in the United States, this results in approximately 40,000 injuries in hospitals daily for a yearly amount of
15 million injured patients. Along with the previous six interventions, six new ones that have been added are (a) prevention of methicillin-resistant Staphylococcus aureus (MRSA) infection, (b) reduce harm from high-alert medications (heparin/insulin), (c) reduce surgical complications, (d) prevent pressure ulcers, (e) deliver reliable evidence-based care for congestive heart failure, and (f) get “boards on board.” In addition to the lives saved, a marked decrease in economic expenditures and liability actions should also result from these initiatives.

The concept of getting the boards on board is very interesting, as traditionally, hospital boards of directors have been very passive in initiating change and accelerating the improvement of care. This concept was discussed in an article by George Annas on the patient’s right to safety. Annas presents the treatise of the judicial recognition that hospitalized patients have an explicit right to safety and that hospitals have a duty to implement patient safety measures. He further opines that hospitals that do little to improve patient safety should be viewed as negligent and be sued for negligence when a violation of the right to safety results in a patient injury. He believes that physicians and lawyers should be allies in the patient safety movement and that the patient’s right to safe medical care can only be pursued by a legal claim against the hospital and its board. His argument is strengthened by the example of the adoption by anesthesiologists of pulse oximetry, which markedly improved patient safety but only occurred when judges and juries declared it the standard of care.