Risk Management

Trends in the Duty of Informed Consent

By Paul Weber, JD

[EyeNet, November/December 1997]

A recent decision by the Supreme Court of Wisconsin has augmented the duty of informed consent to include disclosure to the patient of the physician’s level of experience and success rate for a given procedure. For now, this decision is applicable only to physicians in Wisconsin. However, this decision is noteworthy not only for the $6.2 million judgment against the defendant physician in the underlying lawsuit, but also for the debate it has ignited in the legal and medical communities regarding the trend of doctors having to disclose more information to patients, including their own level of experience with a procedure.

The Wisconsin Supreme Court decision arises from the case of Johnson v. Kokemoor. The patient, Donna Johnson, was referred to neurosurgeon Richard Kokemoor, MD, because of excruciating headaches. In the course of the exam he found an enlarging but unruptured aneurysm in the posterior of her brain. He recommended a basilar bifurcation aneurysm procedure. She recalls being told the procedure was safer than an angiogram, likening it to a tonsillectomy (Dr. Kokemoor denies saying this). He told the patient he had done this procedure “several times,” which he defined as “dozens” and “lots of times.” He also told the patient the mortality and morbidity rate was about two percent. It was undisputed that he told her of the risks of death, stroke, or blindness associated with this surgery. Ten days after first seeing Dr. Kokemoor, she had the procedure. As a consequence of the surgery, Ms Johnson, who had no neurological impairments prior to surgery, was rendered an incomplete quadriplegic.

At trial, there was testimony that Dr. Kokemoor only operated on this type of aneurysm twice. Experts for plaintiff testified that the mortality and morbidity rate for this procedure was 11 percent for the world’s best aneurysm surgeons who had performed hundreds of these surgeries and 20 – 30 percent for surgeon’s with limited experience such as Dr. Kokemoor. The Wisconsin Supreme court held that evidence reflecting the surgeon’s failure to disclose his limited prior experience was admissible at trial and did not unduly or unfairly prejudice the doctor. The court stated “when different physicians have substantially different success rates with the same procedure (and that information is material) the court may admit this statistical evidence.” Finally, the court held that it was proper to admit evidence that Dr. Kokemoor should have advised the patient of the alternative of undergoing surgery at a tertiary care facility with a more experienced surgeon in a better equipped facility.

The Wisconsin court did not create a new informed consent standard. Most states already followed the trend towards a duty to disclose what a reasonable person in the patient’s position would want to know. To most physicians, that generally meant discussing complication rates about an invasive procedure; now it may mean discussing a physician’s own “track record.” What is unique about the Kokemoor case is that never before has the disclosure of the doctor’s experience (or failure to disclose such experience) been the primary subject of litigation. Because of this decision, there is now a precedent that plaintiff lawyers will not have to prove the doctor violated the standard of care, but only that the doctor failed to refer the patient to a colleague with a lower complication rate where the patient, presumably, would have had a better result.

One potential liability scenario that emerges as a result of the Kokemoor decision regards what to tell a patient when you are performing a recently learned procedure or technique. Due to technologic advances and marketplace demands, many ophthalmologists are learning new procedures such as refractive surgery or CO2 laser skin resurfacing. Sometimes, in order to be a provider in a managed care plan, an ophthalmologist may have to agree to see and treat patients that they normally would refer; e.g., pediatric strabismus patients. These technologic advances and changes in health care delivery not only create ethical dilemmas, but an informed consent issue regarding what patients need to know to make an intelligent and informed decision about whether or not to undergo a proposed therapy or treatment.

It is OMIC’s view that the current trend towards patients receiving more information compels the prudent ophthalmologist to inform the patient of his or her level of experience with a newly learned procedure or technique. How and whether an ophthalmologist’s “track record” is disclosed will vary depending on the surgeon’s experience with the technique or procedure. There is no “hard-and-fast” rule on when an ophthalmologist should talk about comparative risk with the patient and sometimes there might not be any “comparative data.” However, we can state that an ophthalmologist should attempt to see the procedure from the patient’s perspective and ask: “Would I want to know the level of expertise and experience of my physician if I was undergoing this particular procedure?” This is the question that will be asked if a lawsuit arises and jurors are trying to determine if this information would have been material to a patient’s decision about whether to undergo a particular treatment or procedure. If the answer is “yes,” then the ophthalmologist ought to discuss the issue of experience and comparative risk (if data exists) and document in the patient’s record that such a discussion did in fact take place. Failure to have such a discussion leaves wide open the possibility of a claim applying the ever-expanding duty of informed consent.