Lawsuits are conventional in medical practice.

An unhappy patient hires a malpractice attorney, who hires a medical expert, who interprets the standards of care and generalizes a departure from the standards of care and proximate cause. The preponderance of evidence is 50% certainty plus an ill-defined scintilla, which needs to be only 0.01% to be good enough.

The lawyer sues the doctor, who notifies the malpractice carrier, hires a defense counsel, and hires an expert witness, who goes through these same contortions to opine that there is no departure from standards of care. At trial, the burden of proof is the same, and scintilla is left to the intuition of finders-of-facts who reach a verdict.

There are 46,000 malpractice lawsuits filed annually: 35,000, or 76%, of which are frivolous. Each of one million physicians has a 5% chance of being sued yearly.

There is a medical liability litigation industry with 600 plaintiff firms, 700 defense firms, 60 medical professional liability companies, at least an equal number of self-insurance plans, 50 expert witness referral services, thousands of expert witnesses, 80 special interest groups, and a parade of bureaucrats at all levels of government, organized medicine and the tort system.

To protect themselves against a 5% risk of a lawsuit with a 76% chance of being frivolous, one million doctors either purchase commercial malpractice insurance or affiliate with a health system for protection under its self-insurance. Providers for health plans endure allowable charges and struggle with overheads. Agents of health systems obligate themselves to practice by “resource-based practice guidelines.” In both cases, they subjugate unwitting patients to micromanagement by faceless institutions, leading to more malpractice.

This is American health care.

How can this vicious cycle be broken? The underlying problems are the 35,000 frivolous lawsuits and the expert witnesses behind each. The AMA establishes a code of ethics that requires experts to be unbiased, objective, and nonpartisan, but there is no enforcement. This paper discusses best practices for expert witnesses.

The best practices introduce a concept that, until now, is lacking in convention: enforcement. When you are a defendant and insist that these best practices are used in your defense, you, not the AMA, are the enforcer. In two instances when I am a defendant in a lawsuit, against the instincts of my attorneys, I insist that these best practices are used. To their surprise, the cases are dropped both times, and, in one case,  I am dismissed with prejudice after only five months.

All treatments are divided into ten standard phases, from the first encounter to the last. Each phase in the treatment in question has a counterpart in the standard of care.

Risk of harm is a variance between the risk inherent in any phase of the treatment in question and the risk inherent in the corresponding phase of the standard of care.

Because the standard of care is the safest effective treatment, risks cannot significantly exceed the background risk. As a matter of convenience, the risk for any phase in the standard of care is always the background risk.

When comparing any phase in the treatment in question to the corresponding phase in the standard of care, the risk for any phase in the treatment in question is either the background risk or is higher than the background. The risk of harm is the incremental increase of the encountered risk. The risk of harm is not arbitrary and is justified by mathematics and medical literature research. The observed risk inherent to that phase of the treatment in question is the risk of harm plus the background risk.

How is this better than convention? Experts use the above two concepts to objectively show where and how a departure from standards of care occurs. Also, because of the risk of harm, the proximate cause is not qualitative but quantitative. In the process, experts document and justify their reasoning.

Ultimately, experts determine the risk for each of the ten phases in the treatment. At least one phase will likely have a higher risk than the background risk. It may be different, but it may not be significantly different. Therefore, the sample of all ten risks is considered collectively to determine whether the treatment in question is significantly different from, or the same as, the applicable standards of care.

This requires hypothesis testing. The sample is entered into a standard statistical formula to test the null hypothesis: the risk for the adverse outcome equals the background risk. The level of significance is 0.05. The population mean is the background risk. The result is the p-value.   If the null hypothesis is retained, there is no departure from standards of care. If rejected, there is a departure.

Nothing is left to the intuition of finders-of-facts. The burden of proof is still a preponderance of the evidence (50% plus a scintilla). Certainty in this opinion is certainty in the opposing expert’s opinion, as a scintilla of 45% is to a scintilla of 0.01%. Also, certainty of 50.01% has as much as a 49.99% chance of being wrong.

Finally, because the certificate of merit affirms that best practices are used, the opinion that results fulfill the ethical requirements to be unbiased, objective, and nonpartisan.

How are doctors and their practices affected? This remains to be seen. Challenging convention is lonely. Sometimes, when you stand alone, you know you are right. I am prepared to stand alone. I would rather stand alone in opposition to convention than stand alone when facing litigation. However, the 5% of physicians who are sued for medical malpractice every year and rely on convention for their defenses may not be prepared to do what I do. Until now, they have no choice. Now, they can stand alone or stand by me.

Howard Smith is an obstetrics-gynecology physician.

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