Y516 STUDY NOTES

Lecture Nine: Professional/Patient Relationship II

Respect for patient autonomy underlies the doctrine of informed consent. We take this for granted now, but not so long ago, as we have discovered from some of our cases, husbands didn’t want their wives to know their diagnoses; families didn’t think it was such a good idea that patients knew their diagnoses; patients didn’t want to know their diagnoses and deferred treatment decisions to their physicians; people treated cancer patients as though they had the plague. What does autonomy really mean? It is the right of all persons to make their own decisions in matters of significance to them. And this principle sets boundaries to the doctor/patient relationship.

The principle developed over time. In the 1950’s, courts began to require disclosure of treatment plans to patients. Without doing so, doctors could, in effect, commit a battery---a non-consented touching. In the 1960’s, courts began to require that doctors disclose alternatives and risks of treatments. Courts began to regard the patients’ need for full disclosure of information in order for patients meaningfully to exercise their autonomy. Anything less would be to give lip service to the principle. Thus, the landmark case of Canterbury v. Spence,DC (1972), where a doctor’s obligations are two-fold: 1) to treat skillfully, and 2) to communicate specific information to enable a patient to make an informed determination. Where other courts, struggling with the developing principle, found that the doctor’s duty to disclose depended on the medical custom in the community, the Canterbury court held that the disclosure requirement was not dependent on professional tradition, but “[r]espect for the patient’s right of self-determination . . . demands a standard set by law for physicians rather than one” set by physicians which has the effect of law. A patient’s right of self-determination can only be exercised effectively if the patient possesses enough information to make an intelligent choice. How much information then does the patient need? Should “X” have been divulged? Ask: Would it be “material” to patient’s decision? What would a reasonable patient want to know? Note how this eases the P’s burden since the question is not what would a reasonable doctor divulge (which would require expert testimony), but what would a reasonable patient want to know (which does not). But that doesn’t settle the matter entirely. There still must be a causal connection between the omission of material information and the injury itself, which can only occur if the disclosure would have resulted in a decision by the plaintiff to follow a different course of action. Is this a subjective “no” or an objective “no”? Is the jury to decide whether THIS patient would have foregone the procedure or whether a PRUDENT patient would have foregone it? P will give testimony he would have foregone it, but is this just self-serving after the fact? The Canterbury court decides in favor of the objective standard. But we will never know how this patient would have decided because he was never given the chance with all the material information. Does this, then, take the sting out of the failure to disclose? A doctor might purposefully withhold information that this patient might use to decline a procedure when he knows a prudent patient would consent. Which is the right test?

Just how much physician specific information must be divulged? The case of Johnson v. Kokemoor may not be the best to answer this question since this is an outrageous case of a neurosurgeon in a small town with precious little experience in operating on large basilar bifurcation aneurysms who failed to divulge the true extent of his experience to the patient, failed to compare the morbidity and mortality rates between experienced and inexperienced surgeons, and failed to refer the patient to a nearby tertiary care center with surgeons experienced in these cases. Clearly this court wanted to teach this doctor a lesson. But it is illustrative that courts may consider that informed consent not only includes general information about the treatment and its risks and alternatives, but the physician’s own record in treating such matters and how his record compares with others. Other courts and other jurisdictions have felt that it is better to leave MD/DO fitness to perform certain procedures up to institutional peer review. These are known as status risks and some feel their regulation is ill-suited to informed consent laws. This may be particularly true of potential contagious status of physicians, e.g. HIV. Rather than require surgeons to disclose their HIV status to every patient in the consent, the hospital makes a determination if the physician represents an unreasonable risk to patients. If he does, his staff privileges are limited to matters where the risk is felt to be minimal. If he does not, then his HIV status would be treated no differently than any other status risk, e.g. alcoholism, coronary artery disease, narcolepsy, impending divorce or other psychosocial stressor. If it begins to affect the quality of his work, then sanctions may be in order, but this seems an odd matter for informed consent.

How specific must the disclosure be? In Arato v. Avedon, California (1993), the P wanted the court to agree that the D was required to disclose a statistical mortality rate. The D had disclosed substantial information regarding diagnosis, treatment options, and prognosis. The issue was whether the standard jury instructions covering the adequacy of disclosures by doctors should be revised in this case to mandate specific disclosures such as patient life expectancy as revealed by mortality statistics. The court felt it was better to instruct the jury that a doctor is under a legal duty to disclose all material information and let them decide if sufficient info was given than to mandate in each case that particular information must be given.

However a somewhat opposite result was reached in Truman v. Thomas, California (1980). The issue was whether MD’s failure to inform patient of material risks of not consenting to a recommended Pap smear may breach a duty of care. The MD told the patient she should have a Pap smear, but never told her how important it was and that failure to undergo such test could result in cancer and premature death. In this case, the court decided that the specific instruction the P wanted should have been given, i.e. not just that D has a duty to disclose all material information, but failure of MD to disclose risks if test is refused renders MD liable for injury resulting from patient’s refusal if a reasonably prudent person in patient’s position would NOT have refused the test if adequately informed. Obviously, stated thusly, the chances that a jury will return a verdict for the P increase substantially.

Does a physician need to disclose personal interests which may affect professional judgment? In Moore v. Regents, California (1990), a doctor whose interest in the patient appeared more than just therapeutic, was making the patient travel thousands of miles for blood and tissue tests that resulted in the physician patenting a cell line from patient’s T-lymphocytes, which enriched the doctor. Patient was totally unaware of D’s research/economic interests as he was never informed of the same. Thus, patient’s consent was anything but informed. It appeared that many of the tests that P had done were not done for therapeutic, but for research purposes. Research that led D to a lucrative patent. The court decided that an MD seeking a patient’s consent for a medical procedure must disclose personal interests (including research or other economic interests) unrelated to the patient’s health that may affect his medical judgment.

In the Moore case, the P sued the D for failure to obtain informed consent and, as a separate claim, breach of fiduciary duty to disclose material facts. Does the breach of fiduciary duty add anything to P’s claim beyond the failure to obtain informed consent claim? Yes. Informed consent usually relates to providing the patient with a risks/benefits analysis of the procedure/place/performer. Breach of fiduciary duty means that the doctor’s motive for recommending certain procedures may be tainted by his own economic/research motives, and not necessarily in the best interests of the patient. Even if the doctor provides complete information regarding the risks and benefits of the procedure, if the real motive for ordering it is that it will serve the physician’s interest, not necessarily the patient’s, then the breach of fiduciary duty claim is more appropriate and more likely to be successful.

What about managed care? Does a doctor participating in a managed care plan have to reveal the incentive plan, since it rewards physicians for keeping Ps’ claims down, i.e. the fewer the tests ordered, the more money that stays in the plan, the more money available for distribution to the physician? First of all, a managed care plan should explain up-front to those who sign on the reason why their cost of coverage is a lot less than traditional insurance. But the analysis in Neade v. Portes is very to the point. If a patient feels that the doctor’s failure to order a test (because he wanted to keep his costs down) had damaged him, then he already has a claim in negligence against the doctor. A claim of fiduciary breach would add nothing.

Don’t forget that there are exceptions to the general rule of a duty to obtain informed consent. In true emergency situations, where the patient is unconscious or when harm is imminent and there is no time to spend, consent may be implied. The case book also discusses the “therapeutic privilege,” where disclosure itself poses a threat of detriment to the patient that it is contraindicated from a medical point of view. Consider use of this privilege to be very risky. It smacks of paternalism and its day in court may have passed.

This is a good place for you to review the informed consent cases that we went over in class.