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Informed consent
ELSEVIER
Medicolegal Issues
EDITOR'S NOTE The following opinion summaries have been prepared by editors of The Citation, a medical-legal newsletter published semimonthly containing court opinions on several topics of interest to physicians. For subscription information, contact The Citation, Box 3538 R.F.D., Long Grove, Illinois, 60047; phone 708-438-2020; fax 708-43&2299.
Suqical Neurology is grateful to the editors of The Citation for allowing us to publish this information, which. we think will be of interest to our worldwide readership. James I. Ausman,
M.D., Ph.D. Editor
INFORMEDCONSENT
Informed consent has been the focus of much attention by medical practitioners, hospital executives and risk managers, and attorneys. Questions frequently asked about informed consent are: 1) what must be included in an adequate informed consent document; 2) who should obtain the informed consent of the patient; and 3) what constraints do a properly executed informed consent impose on the physician. Some guidance about these issues is provided in the following cases.
CASE 1 SUMMARY Informed consent was adequate even though it did not mention a complication which developed during a TURP. FACTS A 74year-old patient underwent a transurethral resection of the prostate (TURP) on February 21, 1984. The procedure was performed with a spinal anesthetic. Extravasation of fluid from the prostatic capsule into the peritoneal space occurred through a small tear in the prostatic tissue. When the tear was discovered, the patient was taken to an operating room where the physician made a suprapubic incision and inserted drains to evacuate the extravasated fluid. A suprapubic catheter was placed in the bladder. After making slow progress postoperatively, the 0 1995 by Elsevier Science 655 Avenue of the Americas,
Inc. New York,
NY 10010
patient recovered and had no residual ill effects from the surgery. In a malpractice action against the operating physician the patient claimed he was inforrned inadequately of the risks associated with the surgery, and the physician negligently performed the TURP. A trial court returned a judgment in favor of the physician. DEC:lSION Affirming the decision, the appellate court said the risk of perforation was not a material risk. Even if it were a material risk, the patient failed to prove that a reasonable person in his condition would not have consented to the TURP if informed of the risk. The risk of perforation was extremely low and rarely caused significant harm. The patient had a classic case of enlarged prostate with severe symptoms of frequency and urgency and loss of control of his urinary function. A person in that condition would have attached little significance to the insignificant risk of perforation, the court said. The patient failed to prove the urologist either lacked the degree of skill or knowledge possessed by urologists or did not use reasonable care in the application of that skill. There was expert testimony that perforation was a complication which occurred even in ideal circumstances using the utmost care. The physician did not breach the standard of care in failing to recognize the symptoms of perforation with extravasation earlier or in resecting the median lobe of the prostate in its entirety before resecting either lateral lobe, the court said. 009%3019/95/$15.00 SSDI 0090-3019(95)00301-J
496
Ausman
Surg Neurol 1995;44:495-7
REFERENCE Roussel U. Sharp, 569 So.Zd 67 (La.Ct. of App., Oct. 11, 1990)
CASE 2 SUMMARY A physician was not liable on a claim of lack of informed consent by a patient who said she suffered damage to a spinal accessory nerve during a biopsy. FACTS The patient underwent a mastectomy in 1980. A few months later she saw a urologist for an unrelated surgical procedure. He discovered and removed a small nodule located on the left side of her neck above the clavicle. A biopsy showed the nodule to be malignant. In July, 1981 she again saw the urologist and reported the existence of a lump located under the previous biopsy site. He referred her to a physician who recommended a biopsy and chemotherapy. The biopsy was scheduled and cancelled twice during August, 1981 while the patient underwent naturopathic treatment. In September, 1984 the patient returned to the physician’s office complaining of a large ulcerated sore on the back of her head, shooting pains radiating to the side of her head, a cough and congestion in her chest. He discovered three or four enlarged lymph nodes in her neck which she said had been there for several years. The physician recommended and performed a biopsy. Two months later the patient complained of stiffness in her left shoulder. An orthopedic surgeon advised her the stiffness probably was caused by tendonitis due to immobilization. A neurologist administered several diagnostic tests and found no denervation in the muscles. A trial court granted summary judgment in favor of the physician on a claim of negligence, and a jury returned a general verdict in favor of the physician on the informed consent claim. DECISION Affirming the decision, the supreme court said the sufficiency of informed consent was governed by a state law enacted in 1975. The court overruled its decision in an earlier case interpreting the informed consent statute. The court said the informed consent statute established an objective medicalcommunity standard, not a subjective patientbased standard. The facts to be disclosed to the patient were those which would be given by a like
physician of good standing practicing in the same community. To establish a claim based on the doctrine of informed consent, the patient must prove three basic elements: nondisclosure, causation, and injury. Adopting the objective standard as fairer to both the patient and the physician, the court said the patient had to show a reasonable person would have chosen no treatment or a different course of treatment if he or she had been informed adequately by the physician. Although there were errors in the judge’s instructions to the jury, they were not prejudicial to her case, the court said. All the issues necessary for her informed consent claim were presented adequately to the jury. Denial of the patient’s motion for a new trial was affirmed because the conflicting evidence presented on whether the spinal accessory nerve was severed supported the jury’s verdict, REFERENCE Sherwood v. Carter, 805 P.2d 452 (Ida. Sup.Ct., Jan. 24, 1991)
CASE 3 FACTS The patient was 37 years old at the time of an operation to repair two fistulae which developed in her bladder as a result of an earlier operation. During the surgery the physician encountered the patient’s remaining ovary in an enlarged condition and in a location which blocked access to the bladder which he was to repair. He removed the ovary and proceeded to complete repair of the bladder. In an action against the surgeon the patient claimed she had not given informed consent to remove her ovary. A jury returned a verdict in favor of the surgeon, and the patient appealed. DECISION Reversing the decision, the appellate court said the trial judge improperly instructed the jury on informed consent. The trial court instructed the jury that “it is not what she would have thought herself, given the information that perhaps should have been given, if you so find, but what a reasonable person in her situation would have felt.” The appellate court said the primary interest of state law was to have the patient informed of all the material facts from which to make an intelligent choice as to the course of treatment, regardless of whether the patient chooses rationally. The surgeon must have the express or implied consent of the patient to extend the surgery beyond the consented-to procedure.
Informed Consent
Surg Neurol 1995;44:495-7
Patients have the right to determine what will happen to their body, even if that decision may appear irrational to another person, the court said. The only exception to the rule requiring informed consent was if the surgeon encountered an emergency situation that immediately and seriously threatened the patient’s life or health. The appellate court said the jury should be asked to determine whether the surgeon’s unanticipated discovery of the misplaced organ created an emergency in which immediate action was necessary to preserve the patient’s life or health. Absent such a finding, the patient should be entitled to recover for any damages suffered as a result of the unauthorized removal of her ovary. REFERENCE 1. Millard v. Nagle, 587 A.2d 10 (Pa. Superior Feb. 27, 1991)
Ct.,
DISCUSSION Typical informed consent documents recite the procedure(s) to be performed and associated potential adverse effects. All intended procedures should be enumerated to facilitate an informed decision by the patient. After obtaining informed consent, the physician is limited by its content unless an emergency circumstance is encountered which cannot be resolved subsequently without harm to the patient resulting from the delay. It is not reasonable to obtain an informed consent for one procedure and then interpret its meaning in an overly broad manner. Those parts of an operation done for the “convenience” of the patient are inappropriate unless specified in the informed consent. Often physicians sense a burden to include every conceivable complication of a planned procedure even though the complexity of the document be comes burdensome and the patient may be confused. In Roussel v. Sharp a Louisiana court has said informed consent requires disclosure of all risks
497
which are “material.” There are two elements which determine materiality: 1) the existence and nature of the risk and its likelihood of occurrence; and 2:) the relationship between the patient’s condition and the significance a reasonable person would. attach to the risk (i.e. whether a reasonable person in the patient’s position would consent if full disclosure is made). Another measure of full disclosure
Medicolegal Issues
EDITOR'S NOTE The following opinion summaries have been prepared by editors of The Citation, a medical-legal newsletter published semimonthly containing court opinions on several topics of interest to physicians. For subscription information, contact The Citation, Box 3538 R.F.D., Long Grove, Illinois, 60047; phone 708-438-2020; fax 708-43&2299.
Suqical Neurology is grateful to the editors of The Citation for allowing us to publish this information, which. we think will be of interest to our worldwide readership. James I. Ausman,
M.D., Ph.D. Editor
INFORMEDCONSENT
Informed consent has been the focus of much attention by medical practitioners, hospital executives and risk managers, and attorneys. Questions frequently asked about informed consent are: 1) what must be included in an adequate informed consent document; 2) who should obtain the informed consent of the patient; and 3) what constraints do a properly executed informed consent impose on the physician. Some guidance about these issues is provided in the following cases.
CASE 1 SUMMARY Informed consent was adequate even though it did not mention a complication which developed during a TURP. FACTS A 74year-old patient underwent a transurethral resection of the prostate (TURP) on February 21, 1984. The procedure was performed with a spinal anesthetic. Extravasation of fluid from the prostatic capsule into the peritoneal space occurred through a small tear in the prostatic tissue. When the tear was discovered, the patient was taken to an operating room where the physician made a suprapubic incision and inserted drains to evacuate the extravasated fluid. A suprapubic catheter was placed in the bladder. After making slow progress postoperatively, the 0 1995 by Elsevier Science 655 Avenue of the Americas,
Inc. New York,
NY 10010
patient recovered and had no residual ill effects from the surgery. In a malpractice action against the operating physician the patient claimed he was inforrned inadequately of the risks associated with the surgery, and the physician negligently performed the TURP. A trial court returned a judgment in favor of the physician. DEC:lSION Affirming the decision, the appellate court said the risk of perforation was not a material risk. Even if it were a material risk, the patient failed to prove that a reasonable person in his condition would not have consented to the TURP if informed of the risk. The risk of perforation was extremely low and rarely caused significant harm. The patient had a classic case of enlarged prostate with severe symptoms of frequency and urgency and loss of control of his urinary function. A person in that condition would have attached little significance to the insignificant risk of perforation, the court said. The patient failed to prove the urologist either lacked the degree of skill or knowledge possessed by urologists or did not use reasonable care in the application of that skill. There was expert testimony that perforation was a complication which occurred even in ideal circumstances using the utmost care. The physician did not breach the standard of care in failing to recognize the symptoms of perforation with extravasation earlier or in resecting the median lobe of the prostate in its entirety before resecting either lateral lobe, the court said. 009%3019/95/$15.00 SSDI 0090-3019(95)00301-J
496
Ausman
Surg Neurol 1995;44:495-7
REFERENCE Roussel U. Sharp, 569 So.Zd 67 (La.Ct. of App., Oct. 11, 1990)
CASE 2 SUMMARY A physician was not liable on a claim of lack of informed consent by a patient who said she suffered damage to a spinal accessory nerve during a biopsy. FACTS The patient underwent a mastectomy in 1980. A few months later she saw a urologist for an unrelated surgical procedure. He discovered and removed a small nodule located on the left side of her neck above the clavicle. A biopsy showed the nodule to be malignant. In July, 1981 she again saw the urologist and reported the existence of a lump located under the previous biopsy site. He referred her to a physician who recommended a biopsy and chemotherapy. The biopsy was scheduled and cancelled twice during August, 1981 while the patient underwent naturopathic treatment. In September, 1984 the patient returned to the physician’s office complaining of a large ulcerated sore on the back of her head, shooting pains radiating to the side of her head, a cough and congestion in her chest. He discovered three or four enlarged lymph nodes in her neck which she said had been there for several years. The physician recommended and performed a biopsy. Two months later the patient complained of stiffness in her left shoulder. An orthopedic surgeon advised her the stiffness probably was caused by tendonitis due to immobilization. A neurologist administered several diagnostic tests and found no denervation in the muscles. A trial court granted summary judgment in favor of the physician on a claim of negligence, and a jury returned a general verdict in favor of the physician on the informed consent claim. DECISION Affirming the decision, the supreme court said the sufficiency of informed consent was governed by a state law enacted in 1975. The court overruled its decision in an earlier case interpreting the informed consent statute. The court said the informed consent statute established an objective medicalcommunity standard, not a subjective patientbased standard. The facts to be disclosed to the patient were those which would be given by a like
physician of good standing practicing in the same community. To establish a claim based on the doctrine of informed consent, the patient must prove three basic elements: nondisclosure, causation, and injury. Adopting the objective standard as fairer to both the patient and the physician, the court said the patient had to show a reasonable person would have chosen no treatment or a different course of treatment if he or she had been informed adequately by the physician. Although there were errors in the judge’s instructions to the jury, they were not prejudicial to her case, the court said. All the issues necessary for her informed consent claim were presented adequately to the jury. Denial of the patient’s motion for a new trial was affirmed because the conflicting evidence presented on whether the spinal accessory nerve was severed supported the jury’s verdict, REFERENCE Sherwood v. Carter, 805 P.2d 452 (Ida. Sup.Ct., Jan. 24, 1991)
CASE 3 FACTS The patient was 37 years old at the time of an operation to repair two fistulae which developed in her bladder as a result of an earlier operation. During the surgery the physician encountered the patient’s remaining ovary in an enlarged condition and in a location which blocked access to the bladder which he was to repair. He removed the ovary and proceeded to complete repair of the bladder. In an action against the surgeon the patient claimed she had not given informed consent to remove her ovary. A jury returned a verdict in favor of the surgeon, and the patient appealed. DECISION Reversing the decision, the appellate court said the trial judge improperly instructed the jury on informed consent. The trial court instructed the jury that “it is not what she would have thought herself, given the information that perhaps should have been given, if you so find, but what a reasonable person in her situation would have felt.” The appellate court said the primary interest of state law was to have the patient informed of all the material facts from which to make an intelligent choice as to the course of treatment, regardless of whether the patient chooses rationally. The surgeon must have the express or implied consent of the patient to extend the surgery beyond the consented-to procedure.
Informed Consent
Surg Neurol 1995;44:495-7
Patients have the right to determine what will happen to their body, even if that decision may appear irrational to another person, the court said. The only exception to the rule requiring informed consent was if the surgeon encountered an emergency situation that immediately and seriously threatened the patient’s life or health. The appellate court said the jury should be asked to determine whether the surgeon’s unanticipated discovery of the misplaced organ created an emergency in which immediate action was necessary to preserve the patient’s life or health. Absent such a finding, the patient should be entitled to recover for any damages suffered as a result of the unauthorized removal of her ovary. REFERENCE 1. Millard v. Nagle, 587 A.2d 10 (Pa. Superior Feb. 27, 1991)
Ct.,
DISCUSSION Typical informed consent documents recite the procedure(s) to be performed and associated potential adverse effects. All intended procedures should be enumerated to facilitate an informed decision by the patient. After obtaining informed consent, the physician is limited by its content unless an emergency circumstance is encountered which cannot be resolved subsequently without harm to the patient resulting from the delay. It is not reasonable to obtain an informed consent for one procedure and then interpret its meaning in an overly broad manner. Those parts of an operation done for the “convenience” of the patient are inappropriate unless specified in the informed consent. Often physicians sense a burden to include every conceivable complication of a planned procedure even though the complexity of the document be comes burdensome and the patient may be confused. In Roussel v. Sharp a Louisiana court has said informed consent requires disclosure of all risks
497
which are “material.” There are two elements which determine materiality: 1) the existence and nature of the risk and its likelihood of occurrence; and 2:) the relationship between the patient’s condition and the significance a reasonable person would. attach to the risk (i.e. whether a reasonable person in the patient’s position would consent if full disclosure is made). Another measure of full disclosure