A patient has melanoma in situ removed from her face and develops sepsis. She sues her doctor, claiming he should have explained that infection could lead to sepsis and death. Was his warning about the risk of infection enough? What is he required to disclose during his informed consent with his patient?
David Goldberg, M.D., J.D.
Dr. Skin has surgically removed a melanoma in situ from the face of his patient. He has warned his patient, Ms. Doe, about the risks of infection, bleeding and scarring. The surgery is performed without difficulty. Unfortunately, some five days after surgery, Ms. Doe develops cellulitis and ultimately sepsis.
After a lengthy hospitalization, loss of her job and a newly developed fear of physicians, Ms. Doe sues Dr. Skin for negligence. The crux of her case is based on the fact that although she was warned about the possibility of infection, Dr. Skin should have explained to her that infection could lead to sepsis and possibly death.
Should Dr. Skin have discussed that infection can lead to sepsis? Was his warning about the risk of infection enough? What is he required to disclose during his informed consent with his patient?
What are the standards?
There are currently two different standards as to what a physician must disclose to his patient. They are: 1) a physician-centered standard, and 2) a patient-centered standard.
The first court to express a physician-centered standard was Natanson v. Kline in 1960. In Natanson, the patient underwent cobalt radiation therapy to prevent the return of her breast cancer after a mastectomy. The patient sued her physician, claiming that the physician was negligent in not warning her of the risks of radiation therapy, which resulted in severe injury.
The court stated that the physician must “disclose and explain to the patient in language as simple as necessary the nature of the ailment, the nature of the proposed treatment, the probability of success or of alternatives, and perhaps the risks of unfortunate results and unforeseen conditions within the body....” This standard is the language most courts use today in defining what must be disclosed to get informed consent. The court noted that:
Anglo-American law starts with the premise of thoroughgoing self-determination. It follows that each man is considered to be master of his own body, and he may, if he be of sound mind, expressly prohibit the performance of life-saving surgery, or other medical treatment. A doctor might well believe that an operation or form of treatment is desirable or necessary but the law does not permit him to substitute his own judgment for that of the patient by any form of artifice or deception.
This court was the first to create the “professional standard” of disclosure when it held that the “duty of the physician to disclose … is limited to those disclosures which a reasonable medical practitioner would make under the same or similar circumstances.”
Natanson’s professional standard of disclosure was the law of the land for 12 years in the United States. In 1972, however, three different courts modified the Natanson standard by holding that the disclosure standard was what a patient would reasonably need to know in order to make an informed decision – instead of what a reasonable physician would disclose.
This reasonable patient standard, more than the reasonable practitioner standard would give a patient even more autonomy and right of self-determination. It should be noted that the patient-centered standard remains the minority view in this country.
Canterbury v. Spence was the first case to establish a patient-centered disclosure standard. In Canterbury, the patient consented to undergo a laminectomy due to severe pain in his upper back. After the procedure, the patient was left unattended and fell from his bed, paralyzing himself from the waist down.
The patient sued the physician, claiming negligence in the performance of the laminectomy and negligence for failure to warn him of the risk that the procedure may cause him paralysis. The court rejected the professional standard of disclosure as set by Natanson, and followed by nearly every court at the time.
In its criticism of the professional standard, the court stated that “Respect for the patient’s right of self-determination on particular therapy demands a standard set by law for physicians rather than one which physicians may or may not impose upon themselves.” Instead, the court fashioned a standard of conduct that is measured by what is reasonable under the circumstances involved.
Defining the scope
The court elaborated on this standard by discussing its scope of disclosure. The court noted that the scope should not be defined in terms of medical professional judgment because this would be inconsistent with the patient’s right of self-determination.
The needs of the patient are the determinative factor in the scope of what a physician should disclose, the court stated. The court held that “the test for determining whether a particular peril must be divulged is its materiality to the patient’s decision: all risks potentially affecting the decision must be unmasked.”
The court chose to analyze this problem objectively, asking what a prudent person in the patient’s position would have done if he had been informed of all the significant risks. The court chose not to use a subjective standard because it feared that a subjective standard (what this particular patient would have done) would present too much of a risk for the court and jury because of its hypothetical nature.
The court explained that the use of a subjective standard “places the physician in jeopardy of the patient’s hindsight and bitterness. It places the fact-finder (court) in the position of deciding whether a speculative answer to a hypothetical question is to be credited.”
Informed consent theory
Another major 1972 decision that joined Canterbury in creating the patient-centered minority view in the United States was Wilkinson v. Vesey. In Wilkinson, a patient underwent radiation therapy after the physician diagnosed probable lymphoma. As a result of the radiation therapy, the patient’s skin on his chest and back necrosed and eventually required plastic surgery. The patient sued the physicians, claiming the physicians failed to disclose all possible risks of the radiation therapy, thus failing to get the patient’s consent.
Like Canterbury, the Wilkinson court also criticized the physician-centered standard on what to disclose. The Wilkinson court noted that the requirement of expert testimony undermines the fundamental principle underlying the doctrine of informed consent, which is the patient’s right to do as she wishes with her own body.
The court held “the requirement that a patient obtain an expert to evaluate the disclosures … undermines the very basis of the informed consent theory - the patient’s right to be the final judge to do with his body as he wills.”
It would seem likely that Dr. Skin, in a “reasonable medical practitioner” jurisdiction, is not likely to lose his case. In a “reasonable patient” jurisdiction, the final conclusion is not so clear. His standard of care may or may not be your standard of care. DT