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Informed consent: Variations and exceptions of this doctrine
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The informed consent doctrine requires the physician or surgeon inform the patient of the (1) benefits; as well as the (2) inherent, material risks; and (3) alternatives of a medical intervention. During the last 50 years, courts have created exceptions or variations from this doctrine that make its application more complex.
The ruling for Nishi v. Hartwell held the physician duty to disclose the benefits, risks and alternatives of a procedure to a patient is not absolute. In this case, the patient became paralyzed from an injectable dye given during a thoracic aortography procedure. The patient claimed he was unaware of the risk of paralysis from the dye. The physicians testified this information was withheld because they feared the patient would overreact and elect not to undergo the necessary procedure.
The Nishi case asked: Are there circumstances when informing a patient of certain risks can cause more harm than good? The court ruling affirmatively answered this question and, in so doing, established what has come to be known as the therapeutic privilege exception to the informed consent doctrine.
B. Sonny Bal
Lawrence H. Brenner
Analysis
The Nishi court described the physician’s fear of disclosure as inducing an “... adverse psychosomatic reaction in the patient ... ” The court acknowledged “The doctrine of informed consent imposes upon a physician a duty to disclose to his patient all relevant information concerning a proposed treatment, including the collateral hazards attendant thereto, so that the patients consent to the treatment would be an intelligent one based on complete information.” The court went on to state that the informed consent doctrine is subordinate to the physician’s fiduciary obligation to do what is in the best interest of the patient. Thus, the court remarked that “ ... the doctrine recognizes that the primary duty of a physician is to do what is best for his patient and that a physician may withhold disclosure of information regarding any untoward consequences of a treatment where full disclosure will be detrimental to the patient’s total care and best interest.”
Unfortunately, the court was unable to differentiate in any meaningful jurisprudential way when the therapeutic privilege exception applies and under what circumstances this exception relieves a physician of the duty to inform. Indeed, the court acknowledged “No hard and fast rule can be stated as to the circumstances which will excuse withholding a full disclosure and as to the kind of information to be withheld, and that each case will depend on its particular facts.”
Expanding informed consent
In contrast, the ruling in Truman v. Thomas expanded the informed consent doctrine by creating the adjunct doctrine of “informed refusal.” In the case, a physician recommended a pap smear to a female patient, who refused. After her refusal, the physician did not advise of the patient of the risks of rejecting the recommendation and she later died from cervical cancer.
Caroline Poma
The court held that a physician had a duty to disclose all relevant information to a patient about the perils of refusing a recommended procedure. The court also held this need to disclose the risks of refusal was not diminished because the patient had rejected the recommendation. The court stated “As an integral part of the physician’s overall obligation to the patient there is a duty of reasonable disclosure of the available choices with respect to proposed therapy and of the dangers inherently and potentially involved in each. The scope of a physician’s duty to disclose is measured by the amount of knowledge a patient needs in order to make an informed choice. All information material to the patient’s decision should be given.”
The court further stated that “A patient must be apprised not only of the risks inherent in the procedure prescribed, but also the risks of a decision not to undergo the treatment, and the probability of a successful outcome of the treatment. This rule applies whether the procedure involves treatment or a diagnostic test.”
Finally, in the case of Hidding v. Williams, the court may have profoundly altered the informed consent doctrine by holding that the personal characteristics of the treating physician or surgeon are among the risks that should, under certain circumstances, become part of the informed consent process. Williams was an orthopedic surgeon who recommended a lumbar laminectomy to his patient. The patient suffered serious complications and alleged his surgeon abused alcohol, which impaired his performance of the surgery, and that lack of disclosure of the alcohol history amounted to a failure to obtain the necessary informed consent to surgery. The court concurred that Williams had an obligation to inform the patient he was abusing alcohol at the time of the proposed surgery.
In medical interventions, there are those risks inherent to the procedure that can manifest even if the surgery is performed flawlessly. Another set of risks, material risks, can potentially influence a patient’s decision. Many other risks associated with a procedure that play little, if any, role in the patient’s decision-making process are not material risks and do not need to be disclosed. The Hidding court held it was material to the patient’s decision to know his surgeon was abusing alcohol. As the court stated: “Dr. Patrick McClain testified as an expert in the field of addictive medicine. He stated that alcoholism is a gradual disease that progresses over a lengthy period. By the time it develops to the stage where an individual’s professional life is affected, it is in a chronic state. At that point, compensatory mechanisms can no longer disguise the problem and the individual becomes florid and outwardly manifests the illness.”
What do you think?
- Do you believe there should be a therapeutic privilege exception to the informed consent doctrine? If so, under what set of circumstances should it apply?
- Do you agree with the Truman court that the informed consent doctrine should have include informed refusal requiring that a physician or surgeon inform the patient of the material risks associated with rejecting a procedure?
- Based upon the Hidding decision, do you believe a physician or surgeon is required to disclose to a patient that he/she has depression and is taking anti-depressant medications prior to performing a surgery?
- Do you believe there is any other characteristic of a physician or surgeon that is material to a patient’s decision and needs to be disclosed prior to a surgical procedure?
- For more information:
- B. Sonny Bal, MD, JD, MBA; and Lawrence H. Brenner, JD, are partners in the law firm of BalBrenner/Orthopedic Law Center and are the exclusive providers of loss prevention, risk management and quality improvement services for the Orthopedic Physician’s Insurance Company. Brenner can be reached at lbrenner@balbrenner.com.
- Caroline Poma is a second-year law student at the University of North Carolina School of Law, and summer law clerk for the BalBrenner Law Firm.
Disclosures: Bal, Brenner and Poma report no relevant financial disclosures.