The Regulation of Medicine – Reflections Of An Insider

A Death in the Hospital /The Regulation of Medicine – Reflections Of An Insider


I am a member of both groups involved in the Medical Malpractice Crises, that is the Victims and the Providers. I understand the emotions and perceptions of both groups. It is from this vantage point as an “insider” that I offer these thoughts about a future direction in the search for safe health care.

American physicians like to pride themselves as being practioners of the world’s leading health care system. In many respects this is true. The discoveries of American medical researchers and clinical investigators have transformed medical care throughout the world. We are at the threshold of an almost undreamed of understanding and ability to treat disease through breakthroughs in the Human Genome Project.

And yet, there is a silent “cancer” eating away at the fabric of our health care system. Despite the successes of American Medicine, we rank only 37th in the world, according to the World Health Organization, in terms of bringing these successes to all of our citizens.

In the late 1930’s, in an attempt to persuade his citizens that health care was a drain on the national budget and must be provided only to the productive, Hitler created the propaganda movie entitled, “Dasein Ohne Leben” – “Existence Without Life”. The premise was that the chronically sick, with no chance of cure, should be liquidated. The Nazi argument was that health care was expensive and limited financial and human resources were to be rationed. Only those with real Life (Leben) – the healthy and productive – should receive optimum health care. Those with only simple Dasein – Existence – were without real life and would have to accept either lesser care or termination.

Now, at the dawn of a new millennium, ideas reminiscent of Hitler’s evil schemes pervade medical planning. Notions such as “managed care”, “rationing”, “acceptable minimal standards of care”, age limitations (such as in dialysis), and a host of other limits on optimal care are accepted as the norm.

But the result of “Dasein Ohne Leben” thinking is that millions of Americans are without health care coverage and millions are receiving substandard care or no care at all. Many of those who are receiving optimum care have turned a cold shoulder to those who aren’t. Tragically, in America at the dawn of the new millennium, “Care Follows the Buck”.

The benefits of capitalism have a downside when it comes to ethics in medicine. The image of the ‘free wielding capitalist’ has invaded the notion of the holy calling to heal the sick. Increasingly, young doctors entering Medicine look with envy at their peers who, with far less grueling preparation, quickly enter lucrative professions. Once graduated, the young doctor often finds herself or himself loaded down with bills that have to be paid. Large numbers of patients have to be seen to make money. Volume and speed become a priority.

And so, in the midst of all of the wonders of modern American Medicine, exists a ‘silent cancer’ – the growing epidemic of medical malpractice. While the Institute of Medicine of the National Academy of Sciences lists the number of dead from medical error as 44,000 to 98,000 each year, some key members of the National Patient Safety Foundation feel the number may be over 250,000 annually. Who knows what the true rate of injured is each year?

How aptly put the most recent meeting of the National Patient Safety Foundation in Chicago (May 7-9, 2000). It was called, “Racing Against Time”.

The final day of the meeting was entitled, “The End of the Beginning”. This took the stirring words of Churchill during World War II. The premise of this final session was that much of the preliminary work in facing up to the problem of medical error had been addressed by American Medical Association. This meeting marked a symbolic “end” to this phase. Now, organized medicine and medical planners must turn their attention to solutions.

This use of Churchillian phrases was also aptly put. For, in truth, the issue of medical error should be perceived as the moral equivalent of war. If a quarter of a million people are dying every year from medical error, what could be a greater national emergency? To date, this “silent slaughter” (a phrase coined by a prominent victim, Elizabeth LaBozetta), has been one of the most well hidden issues in the country.

Medical Regulation – What’s Wrong?

1. Our system of medical tort law has been a major factor in turning many physicians into liars. Its existence as the primary regulator of medical practice is perhaps the biggest single impediment to real progress in designing a new medical regulatory system.

2. Regulation by state medical boards is also a failure. The medical boards, for the most part, are complaint driven. If no complaint is raised, there is no recognition of problems. As Dr. Lucian Leape pointed out, only 1 out of approximately 8 cases of medical error ever sees the light of day. And, it is well-known to Victims that the state boards go out of their way to protect physicians and hospitals, most likely to reduce their exposure to civil suits.

These are broad generalizations, admittedly. However, neither the civil court system nor the state medical boards have served to bring definitive reform in diminishing the extent of medical error. In fact, there is sort of “schizophrenia” to a system in which certain cases (almost always those that will make money for the lawyers) go the route of tort law and others go into the administrative law of the state boards.

It is generally agreed that the theoretical deterrent value of civil litigation has been a failure in controlling the malpractice epidemic Physicians well know that skilled lawyers can often “get them off”. And the state board system (which does not regulate but rather responds to complaints) is seen by physicians as a nuisance rather than a regulator of their activities.

Our website was the first to draw the comparison between safety in Medicine and safety in the Airline Industry. Yet, the comparison only goes so far. One reason air travel is so safe is that when accidents occur, the pilot goes down with the plane. This has encouraged responsibility.

By contrast, when a patient is injured or dies, there is often no accountability. Imagine how quickly the issue of medical error would be addressed were the responsible medical provider to suffer the same fate as a negligent airline pilot who makes a fatal mistake.

In all seriousness, it is true that “To Err Is Human”. Standards of care must be developed in medicine, far more effective than exit today, to provide responsible regulation.

Victim Compensation:

Fifty years ago, in “Reason and Law”, the famous teacher of philosophy Morris Raphael Cohen stated, “punishment must fit the crime, not the criminal.”

As a culture, America has decided that at least in health care the vast amount of negligence committed by physicians should not be considered “crime.” Doctors are not to be considered “criminals” for the injuries they cause. The percentage of the accidents that is in fact due to simple negligence, as opposed to criminal negligence is unknown.

But if, as a people, we have decided to indemnify physicians, what about the Victims? We have a chaotic, fragmented “system” that, at theoretically, should supply money to the injured to both cushion their economic damage and provide some consolation. In practice, what we have as a system of compensation is a sort of ‘medical malpractice casino’. Lawyers take cases, not on merit, but on how much money they will receive. They hide under the fiction, with no basis in fact, that the tort law serves is a deterrent to other physicians.

We have a state board system that can only sanction physicians. It does not compensate medical victims. In many instances, boards have actually ‘covered up’ cases. This has occurred, no doubt, to decrease the rate of prosecution of these cases in the civil courts and thereby limit the number of malpractice awards.

From the point of view of the culture, physicians are to be indemnified for their actions, from the point of view of the Victims, even simple ‘negligence’ is experienced as a ‘crime’ once it is discovered. Try to tell an individual, whose life is tragically and permanently altered by a missed diagnosis, a failed procedure, or a surgical mistake, that she or he is not a victim of a crime.

Our culture has denied most Victims both justice and compensation. It is a situation that has been described as “Justice Denied”.

The survivors of malpractice must fight to receive compensation. As our case has highlighted, this is a tortuous process that leads the survivors drained. On average, these cases wend their way through the civil court system over a 5-year period. There is no doubt a well thought out rational behind this. By stringing these cases out, the Victims are drained emotionally. When the legal process is completed, the injured and/or the family are all to happy to settle – most often with a promise to never again talk publicly about what happened to them.

Since only 1 in 8 cases ever reach the legal system, the most harmed patients have neither justice nor money in the end. And, as a culture, we have permitted this. The interested reader should pause for a moment and think again of “Dasein Ohne Leben”. In the error of our approach to medical malpractice, we have fallen into a dangerous similarity to the pattern of thought of National Socialism. That is, the needs of the healthy outweigh any ethical concerns for the needs of the sick.


We are in the moral equivalent of war. And as in war, a grand strategy for winning must be devised. It is not sufficient to try to change bits and pieces of the medical regulatory system. Total and swift change is needed.

As discussed, the medical tort system is at the core of the problem. Concerned about the huge sums they pay for malpractice coverage, and terrified of losing a case and having to pay future premiums that would severely decrease their incomes, doctors and hospitals have learned to lie skillfully about their misdeeds. Every hospital has a risk management office whose very function is to skillfully lie about “accidents” in order to reduce risk.

But all this lying has impeded full understanding of both the problem of medical malpractice as well as its solution. No one becomes a physician to hurt people. Particularly now, where competing careers offer the promise of more money with less arduous work, young people go into medicine with a sense of idealism. Were such idealistic physicians to be the dominant force in medicine, a truly effective system of medical regulation would have been devised long ago.

It is necessary to abolish the medical tort system. Political courage is needed to resist the pressures of the medical malpractice lawyers. They will be the only class hurt by the needed change. They have been the only group that in the aggregate has benefited under the current system.

What should replace the tort system is a type of “No-Fault” scheme, similar to that of workman’s compensation law. One example of this is the Patient Injury Compensation Act of Finland described in “Law Reform and Medical Regulation”, Dartmouth, 1995, Sheila A.M. McLean, editor. In the Finnish scheme, payments to injured patients do not require proof of fault on the part by physicians. All health care providers are required to take out insurance against patient injury. Injured patients apply to the Patient Injury Association for compensation. In the volume referred to above, Professor Wadlington of the University of Virginia described the “No Fault” approach in great detail. There have been several well thought out proposals.

Under the current medical tort system, very few Victims ever receive compensation. Yet to achieve real progress in the regulation of medicine, all known medically injured must be compensated. The argument is made that this would not be financially feasible. Yet, considering the vast waste in national productivity caused by medical malpractice, and the vast sums spent on malpractice insurance and other steps taken to defend against civil liability, from the macroeconomic perspective the “No Fault” approach would be less expensive.

The current system of medical regulation needs fundamental restructuring. The state board system must evolve into a regulatory apparatus that is much more effective and comprehensive.

Given the importance of health care, it is necessary to bring all the various governmental organizations that now have regulatory authority over the pieces of the ‘health care pie’ under one central authority. All of the state medical boards must then be federalized and come under the supervision of this central federal agency in Washington. The various standards that are currently adopted by the chaotic mix of federal, state, and local authorities as well as private organizations such as the JCAOH that now have their own pieces in health care regulation must be made uniform and mandated. For example, the language of the Accreditation Commission for Graduate Medical Education states often that medical students, interns, and residents “should” have appropriate supervision. The central federal regulatory body will need to mandate the change of “should” to “must”.

With the federalization of the state boards, and the adoption of uniform standards of health care delivery across the country, there will be a need to enforce these standards at the local level. Malpractice law reform will remove the threat of lawsuits. There will be no need for the so-called, “risk management offices” that now serve largely to cover up hospital-based malpractice. Instead, the federally supervised state authority will regulate each hospital through a state supervised “Quality Assurance” office. Thus, the uniform nationwide standards of health care delivery will be disseminated and applied at the local hospital level.

This same pattern of federal, state, local supervision can extend to the various types of group practices that are an increasing form of health care delivery. Individual health care providers must adhere to standards of documentation and health care. Unannounced checks by local regulators will become the norm.

In a well-regulated system, malpractice will decline. Yet, “To Err is Human” and medical injury will not disappear. When a bad outcome due to negligence does occur, a new mechanism for investigation, compensation, and resolution must be developed. The principle of regulation and adherence to practice guidelines must apply to all aspects of the medical delivery system.

In one scheme, the state regulatory body would handle all aspects of case resolution when medical injury does occur. This would include the detailed investigation of what went wrong as well as what consequence would be applied to the negligent health care provider. This would range from no consequence to loss of license. The state authority would also dispense compensation to the Victim.

It is on this issue that an independent judicial system may need to be involved. In Germany, there are “medical judges” with special interest and training in medicine. It may be that in a revised American system, investigated cases would be brought before a medical judge for final determination. This could provide an appellate trial mechanism for those who disagree with the decisions of the state regulatory authority.

This proposal seeks to apply the notions regulation and ‘No-Fault’ to health care delivery. Medical care can be complex, problematic, and unpredictable. The potential for error exists for even the best providers. And even the ‘best’ have committed mistakes. The need is to have a system of regulation that the public can truly trust. We get onto an airplane with no knowledge of who the pilot is simply because we have a sense of trust in our government and the Federal Aviation Administration. The public needs this same trust in a new health care regulatory authority. The issues that are so important to the public now – profiling, malpractice trials, etc.- will become less so once they know that the lies and cover-ups on the part of government, courts, lawyers, and doctors are a thing of the past and there is a regulatory system that works and is deserving of trust.

While physicians will be free of onerous malpractice insurance, there is an additional issue they must acknowledge. While it is true that “To Err is Human,” it is also tragically true that “To Kill is Human”. There is an unknown percentage of so-called medical malpractice that is actually criminally negligent in nature. By this is meant injury or death that was far beyond simple negligence. Doctors are human and subject to pressures and temptations. They have enormous power over human life, and flawed physicians can commit great damage.

As is the case in Germany, a determination is needed as to whether a negligent act constitutes criminal negligence. It is possible to set standards in this area. For example, in Germany, any medical procedure not done with complete Informed Consent is classified automatically as a criminal medical act and prosecuted criminally. The failure to address this issue on the part of our culture should be a source of real guilt for all Americans.

We urgently needed is to develop a system of regulation that can be trusted. Certainly more study is necessary, but the creation of responsible healthcare regulation along the lines of this proposal could be put into place now. Efforts to deny the “silent slaughter” in American medicine are misguided and ultimately destructive of our government and culture.

So these are the thoughts of an “insider”. As an insider of both groups, I know that neither will be completely satisfied with this proposal. The Victims will resent the assertion that the malpractice tort system must be set aside and their hopes of delivering their own justice must be abandoned. For those acts of malpractice that are truly negligent, however, what is needed is not punishment but fair compensation and corrective steps to prevent similar acts occurring in the future. What the survivors of medical malpractice will find worthwhile is that a plan is presented for a new system of medical regulation, far more extensive than exists now.

Physicians certainly would be happy that they would be freed of fear of trial for negligent practice. In a ‘No-Fault’ system, they would have to pay into an insurance fund for the compensation of patients, but this would be less than their malpractice premiums. In one scheme being discussed, tax money would be applied as well.

What physicians must accept in this system, however, is that the blanket of immunity extends only to those acts that arise from simple negligence. Clearly, where laws are broken and medical acts are criminally negligent in nature, criminal prosecution is warranted. The privilege of caring for life carries with it the highest moral responsibility.

Truly, “To Err is Human”. Regulation must be the watchword in the quest for safe health care.


Stephanie and Ralph Speken