Medical science brings innovations in patient care at an astounding pace today - new chemotherapeutic agents, coated stents, and minimally invasive surgery are just few recent examples. For physicians, though, the specter of malpractice liability can overshadow the marvel of practicing in this era. Many physicians are working in a volatile liability environment; they face spiraling costs for malpractice insurance, have difficulties purchasing liability coverage at any price, and see record payouts in a growing number of claims against their colleagues. The American Medical Association (AMA) has declared that at least 20 states are currently in a malpractice “crisis,” with another 24 states showing early signs of an impending crisis.

There have been two comparable periods of instability in the last thirty years, but these predecessor crises differ from the current one in important ways. First, while physicians mainly experienced dwindling options for obtaining coverage in the mid-1970s (i.e., availability) and exorbitant prices in the mid-1980s (i.e., affordability), the current crisis appears to have elements of both availability and affordability.

Medical indemnity is not usually the stuff of high political and social drama in Australia. When the biggest medical defense organization went into voluntary liquidation in 2002, this all changed. Newspapers carried stories on an almost daily basis about the actual or possible negative impact of the “crisis” on doctors, hospitals, and communities. Doctors became increasingly vocal in their criticisms and expansive in their claims. Their political organization, the Australian Medical Association, lobbied powerfully and successfully for government intervention to address the problem of dramatically escalating premiums for some doctors. This, combined with a broader public relations campaign about public liability insurance, resulted in significant changes in the law at both the federal and state level - not just in the area of medical negligence but in relation to most personal injury litigation.

The genesis of and reasons for current medical indemnity problems in Australia have been the subject of much speculation and little rigorous analysis.

It is often thought that there is a “crisis” or something akin to this in the field of medical malpractice in the USA and from time to time, as will be shown, there are suggestions that a similar situation could exist in the UK. This paper will examine what might be meant by the expressions “malpractice” and “crisis” in relation to the UK. It will be argued that there is no evidence to suggest that anything as dramatic as a crisis exists, and that what current concerns exist about medical malpractice and litigation are not based upon an existing or impending crisis. Further, it will suggest that evidence points to medical litigation had reached a plateau, and that, due to a number of factors, if there were a serious problem it is likely to be on the wane.

In China, there have been numerous reports that doctors or other health care workers have been attacked by patients or members of patient’s families. From 2000 to 2003, there were 502 reports of violence against health care workers in the city of Beijing, in which 90 health care workers were wounded or disabled. From January 1991 to July 2001, in Hubei Province, 568 attacks on health care facilities and workers were reported, and some health care workers were even killed. In Jiangsu Province, from 2000 to 2002, violent events against health care facilities and workers increased by 35% every year, with an average of 177 such events occurring each year. Those acts of violence have been attributed, in part, to the inadequacy of the legal system for handling medical disputes that was in effect prior to 2002.

Too many patients are injured in the course of medical care. This truth is as distressing now as it was four years ago when it began an article in this journal’s last similar symposium. Many or most injuries seem preventable. Yet today’s systems of care and of oversight of care too often fail to prevent them, despite generations of increasing legal intervention. Few injuries are litigated, even fewer addressed through medical peer review or state disciplinary authorities. The Institute of Medicine’s (IOM’s) landmark report To Err Is Human brought patient safety to national attention when released in late 1999. Half a decade later, significant reduction of injury remains a distant prospect, despite some apparent progress.

Over fifteen years after first reporting to the State of New York, the Harvard Medical Practice Study (HMPS) continues to have a significant impact in medical malpractice policy debates. In those debates the HMPS has come to stand for four main propositions. First, “medical injury… accounts for more deaths than all other kinds of accidents combined” and “more than a quarter of those were caused by substandard care.” Second, the vast majority of people who are injured as result of substandard care do not file a claim. Third, “a substantial majority of malpractice claims filed are not based on provider carelessness or even iatrogenic injury.” Fourth, “whether negligence or a medical injury had occurred… bore little relation to the outcome of the claims.”

Medical malpractice researchers have long known that the HMPS provides far stronger support for the first two of these propositions than for the last two; the HMPS was not designed or powered to reach strong conclusions about the validity of medical malpractice claims.

The United States is in its fifth year of what is now widely referred to as “the new medical malpractice crisis.” Although some professional liability insurers have begun to report improvements in their overall financial margins, there are few signs that the trend toward higher costs is reversing itself - particularly for doctors and hospitals. In 2003-2004, the presidential election and tort reform proposals in Congress brought heightened public attention to the need for some type of policy intervention to ease the effects of the crisis.

The darling of tort reformers at both the federal and state levels has been legislation to limit, or “cap,” damages awarded to plaintiffs in malpractice cases. Health care provider groups, liability insurers, and the Bush Administration have all seized on the example of California's MICRA law, which since 1975 has capped noneconomic damages in malpractice cases at a flat $250,000, as the path to financial recovery.

The United States Supreme Court has long recognized the value of scientific evidence - especially when compared to other types of evidence such as eyewitness identifications, confessions, and informant testimony. For example, in Escobedo v. Illinois, the Court observed: “We have learned the lesson of history, ancient and modern, that a system of criminal law enforcement which comes to depend on the ‘confession’ will, in the long run, be less reliable and more subject to abuses than a system which depends on extrinsic evidence independently secured through skillful investigation.” Similarly, in Davis v. Mississippi, the Court commented:

Current methods of forensic DNA profiling (known also as DNA fingerprinting and DNA typing), based on Polymerase Chain Reaction (PCR) amplifications of a varying number of Short Tandem Repeat (STR) loci found at different locations on the human genome, are regularly described as constituting the “gold standard for identification” in contemporary society. At a time when criminal justice systems in Europe and North America increasingly seek to utilise the epistemic authority of a variety of sciences in support of the apprehension and prosecution of suspects and offenders, genetic science and recombinant DNA technology are often singled out for particular approbation. Indeed, the development and application of DNA profiling has been widely described as the “greatest breakthrough in forensic science since fingerprinting.”

Prior to the implementation of PCR based extraction and amplification methods in the 1990's, the initial uses of DNA fingerprinting (based on Multiple and Single Locus Probes) were largely confined to reactive forensic casework.

In this era of globalization, as the health problems of poor countries and rich countries become increasingly intertwined, medical research is being conducted at the international level. For example, a research study may be sponsored by a developed country and conducted in a resource-poor country to address health problems faced by both nations. The globalization of medical research is, in effect, quickly outpacing the development of internationally accepted ethical guidelines for the conduct of research. For many medical researchers working in resource-poor countries, ethical decision-making is like sailing in the days before modern navigation; one is never quite sure where one is, or in what direction one is headed. Our aim in this article is to fix a few navigational points on an ethical compass to guide biomedical researchers from developed countries working in resource-poor countries.

Just as one of the principles underlying the Hippocratic Oath is “First, do no harm,” a principle underlying medical research ethics may be “First, do not exploit.”

In the research ethics literature, there is strong disagreement about the ethical acceptability of placebo-controlled trials, particularly when a tested therapy aims to alleviate a condition for which standard treatment exists. Recently, this disagreement has given rise to debate over the moral appropriateness of the principle of clinical equipoise for medical research. Underlying these debates are two fundamentally different visions of the moral obligations that investigators owe their subjects.

Some commentators and ethics documents claim that physicians, whether acting as care givers or researchers, have the same duty of beneficence towards their patients and subjects: namely, that they must provide optimal medical care. In discussing placebo surgery in research on refractory Parkinson's disease, Peter Clark succinctly states this view: “The researcher has an ethical responsibility to act in the best interest of subjects.”

Some authors argue that the ethics of medical care and the ethics of research differ, and that it is a mistake to conflate the two. They propose “that medical research and medical treatment are two distinct forms of activities, governed by different ethical principles.” This raises the question of whether physicians who are also clinical investigators may separate their role as physician from that of researcher when they are involved in clinical trials, thereby avoiding the obligations required in the physician-patient relationship. Miller and Brody suggest that medical training is to blame for what they believe is the physicians’ tendency to confound the obligations of research and practice. “Physician-investigators, after all, went to medical school” they explain. They believe that considering research with patients outside the ethical framework of the physician-patient relationship may be “difficult and threatening” to physicians who have “psychological needs” to consider the ethical obligations flowing from their relationship with their patients.

One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes his medical patients, or whether they differ in any fundamental way.

Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior.

Problems in the field of health law often force tradeoffs between uniformity and particularity in health care decision-making. Patients are highly diverse in terms of their basic health status, willingness to accept risk or uncertainty in new treatments, and ability to pay for care. And health care experts - doctors, research scientists, insurance company reviewers, and health economists - are similarly diverse in their perception of the best treatment and payment structure choices. In a world with such persistent heterogeneity of opinions and preferences, a society's choice between centralized rules for treatment and payment and a more diffuse decisional regime is both crucial and controversial. Opt for a uniform national rule - say, a federal statute governing treatment standards, drug approval, or health finance - and many beneficial autonomous transactions between doctors and patients are squelched, with possible detrimental effects on population health and medical innovation.