The History of Informed Consent

To understand the present-day theory of informed consent, it is important to understand the evolution of the theory of informed consent from the historical perspective. The historical incidents where physicians have been subjected to compensation, either in physical or financial form, are not rare. Four thousand years ago, medical malpractice was recognized and was punishable as a crime. The sixth Babylonian king, Hammurabi (1792–1750 bc ), who lived in modern-day Iraq and eastern Syria, is best known for his testimony of legal codes, engraved on a 2.25-meter-high diorite stone stela that is on exhibit at the Louvre in Paris. The code has 282 laws pertaining to various civil and criminal matters with a description of their punishments. Code 218 says, “If a physician operate on a man for a severe wound with a bronze lancet and cause the man’s death, or open an abscess in the eye of a man with a bronze lancet and destroy the man’s eye, they shall cut off his hands” (Code No. 218 of Hammurabi). Although the punishment of cutting the fingers of erring physicians is not comparable to present-day medical malpractice, the financial payment does have resemblance to modern-day medical litigation settlements. Codes 219 and 220 say that “if a physician makes a wound and cures a freeman, he shall receive ten pieces of silver, but only five if the patient is the son of a plebeian or two if he is a slave.” Sushruta Samhita , a treatise on surgery from India written in the 3rd century BC, describes the need for obtaining the consent of the king in certain treatment scenarios like, “If surgical intervention is not done then the patient will die and after surgery it is not certain if surgery will be beneficial.”

In ancient Greece, the patient’s participation in decision-making on medical treatment was considered undesirable. It was thought that any discussion regarding the possible complications would decrease the patient’s trust and confidence in the treatment. In the era of enlightenment, the medical community still felt that “deception” was required to facilitate the treatment. There were dichotomous views as to whether to disclose the prognosis to the patient or to hide it. To effect a treatment cure, it was widely felt that authority must be coupled with obedience. The doctrine of assault versus battery evolved in early English common law. Gradually informed consent has emerged to be more patient oriented, and it has been established that a well-informed patient is a master of his or her own body. Since the 1930s, the courts have largely moved away from the battery theory of informed consent and have adopted the concept of negligence in its place. The negligence theory puts more emphasis on professional standards and expertise than the battery concept. During the 20th century, the courts extended the English common law tort doctrine of negligence to the field of surgery by equating negligence with breach of duty, and breach of duty with incomplete patient consent. The present concept of informed consent has evolved with several landmark judgements in the last century. It is essential that these cases be analyzed to understand the evolution of the present-day theory of informed consent. The first recorded case of medical litigation was Stratton vs. Swanlond in 1374. The case pertained to a surgery on the hand of a patient, which was injured in trauma. The surgery did not result in eradicating the problem. The patient contended that the promised cure was not achieved. The judge held that the physician could be held responsible if harm came to the patient as a result of surgery, and that he could not be held responsible if the intended cure was not achieved despite his best efforts.

In the aftermath of World War II, several trials were held against Nazi Party members for war crimes, under the orders of President Harry Truman. The trials began on December 9, 1946, in Nuremberg, Germany, and came to be known as the Nuremberg trials. One of the trials, the so-called “doctors trial” focused on the inhuman medical experiments that were carried out by the Nazi physicians. The trial promulgated six ethical principles of medical experiments, which later came to be known as the Nuremberg Code. The first principle of the code states the absolute need for voluntary consent in medical experiments. The Nuremberg Code has not been officially accepted as a law by any nation or medical association, but it has formed the basis of many guidelines worldwide.

There are well-known cases involving neurosurgery that have shaped the legal doctrine of informed consent in the United States. The case of Canterbury vs. Spence is a landmark case that defined many issues of informed consent in present-day practice. Jerry Watson Canterbury was an FBI clerk who developed a prolapsed intervertebral disc in 1958 at the age of 19 years. He consulted a well-known neurosurgeon, Dr. William Spence. He was diagnosed to have a prolapsed disc at the T4 level as confirmed by a myelogram. Spence recommended that the patient have a laminectomy. After the surgery, Canterbury had a fall from his bed while still being hospitalized and developed paralysis from the waist down with urinary incontinence. Canterbury underwent a second operation due to the neurologic deterioration. He made some recovery in his motor function but continued to have issues with urinary incontinence. The court held that Spence was negligent in obtaining complete consent. On March 15, 2017, Canterbury passed away, and an obituary was posted in The New York Times about him. This case was a landmark case in the medicolegal context. Before this judgement, the onus of soliciting information about treatment resided with the patient. Describing the risks involved in the proposed treatment was at the doctor’s discretion. He was held negligent only when the treatment was carried out against the wishes of the patient. The 1972 ruling in this case made it mandatory for the doctor to disclose all pertinent information relating to the risks of treatment, and to inform the patient of any alternative forms of treatment available. According to professor Alan Meisel, “The opinion is the cornerstone of the law of informed consent not only in the United States, but in other English-speaking countries, too.” The case shifted the perceptions from “professional practice standard” to a “reasonable person standard.” The Johnson vs. Kokemoor case has opened a new dimension to informed consent. Donna Johnson was diagnosed during an evaluation of her headaches to have a basilar aneurysm. She consulted Dr. Richard Kokemoor, who advised surgery for the aneurysm. Kokemoor informed the patient that he had performed the procedure “dozens of times” and compared the risks involved with those of a tonsillectomy or gallbladder surgery. Kokemoor estimated the risk of death due to surgery at 2%, when in fact it was close to 30% when performed by inexperienced surgeons. Johnson underwent the surgical procedure but developed quadriparesis, incontinence with speech, vision problems, and swallowing disturbances. Johnson filed a suit against Kokemoor, and the jury deliberated in favor of Johnson. The court held that the actual risks involved in the surgery were not conveyed to the patient. Kokemoor had not disclosed the difference in results between experienced and inexperienced surgeons, and he had not disclosed that the mortality rate in the hands of inexperienced surgeons was much higher than what had been disclosed to the patient. It was brought to evidence that Kokemoor had performed the aneurysm clipping in six patients after his residency and had operated on a basilar aneurysm only twice. The plaintiff contested that the doctor should have referred her to a more experienced tertiary care center like Mayo Clinic, which was only 90 miles away. The court held that the defendant failed to do the following: divulge the extent of his experience in performing the specific operation, compare the mortality and morbidity between experienced and inexperienced surgeons, and refer the plaintiff to a more experienced treatment center. The Wisconsin Supreme Court stated that “physicians must provide comparative risk in statistical terms to obtain informed consent.”