This article is the first in a series of 4 derived from a symposium on malpractice risk management at the 91st Clinical Congress of the American College of Surgeons, San Francisco, Calif, in October 2005. Mr. Goodman updated his comments in October 2006.
James M. Goodman, JD
Common errors in self-defense
Claudia Dobbs, MA
Patient safety as risk management tool
Thomas J. Donnelly, JD
Responsibilities in obtaining informed consent
James M. Nelson, JD
The concept of informed refusal is similar to that of informed consent. However, in working with physicians for 30 years, I have found that informed refusal is not nearly as well understood as informed consent.
Informed consent means a patient has the right to understand the risks of death, serious bodily injury, or other common outcomes of an operation or medical treatment. The patient also has the right to be told about the risks of refusing a particular operation, test, medication, or other medical intervention.
If a patient is reluctant or noncompliant, you may not be doing enough if you simply document that he or she refused your recommendation of treatment. You should also make a record of your efforts to explain to the patient the risks of refusing that treatment.
Informed refusal unfolds in 4 steps
Keep in mind these 4 components:
- The physician determines the patient needs a particular operation, test, medication, or other type of medical intervention
- The physician tells the patient about the needed intervention
- The patient refuses the recommended treatment for any reason: “I don’t think I need that test.” “I don’t like needles.” “I don’t care if I die.”
- The physician explains the risks of not having the treatment so the patient can make an informed decision when refusing it.
The courts first recognized the concept of informed refusal in a case in California more than 30 years ago. A woman seeing her long-time gynecologist was advised to have a Pap smear. Despite repeated recommendations, the patient declined the test. She later developed cervical cancer and sued her physician, claiming malpractice.
Because the physician and patient agreed the former had recommended the Pap smear, the trial judge threw the case out.
He determined it was the patient’s fault that she did not get the test that could have alerted her to the presence of cancer.
A higher court, however, reversed that decision because the patient had the right to make an informed decision in refusing the test—informed refusal.
The appeals judge ruled the gynecologist had a duty not only to recommend the test, but also to make sure the patient understood the consequences of her refusal. Because the evidence of informed refusal was lacking, the case was returned to the lower court.
Case: Patient refuses CT scan, dies; suit follows
The issue of informed refusal was used in a 1996 trial, about 20 years after the doctrine was first recognized in California. The emergency department (ED) physician in that case was found responsible for a patient’s death.
The patient, who had a long history of alcoholism, had fallen at home and struck his head. He was unconscious briefly before his wife took him to the ED. Although the examination did not reveal any neurologic abnormalities, the physician recommended a computed tomography (CT) scan of the head.
According to the physician, the patient and his wife refused the CT scan because they did not have health insurance. The physician failed to document his recommendation of the scan or the discussion in which the patient refused it. The patient and his wife left the ED. The next day, the patient died of multiple subdural bleeds. The widow sued for wrongful death.
Was the recommendation made?
During the trial, the physician testified that he had recommended a CT scan to the patient and his wife. The wife denied receiving such a recommendation. The trial attorneys focused considerable attention on whether the recommendation had actually been made. No one really focused on whether the physician advised the patient about the risks of refusal.