by Michael S. Kavic, MD
ETHICS
Life in medicine occurs within a legal framework that begins in medical school and continues throughout clinical practice. The framework is not new and has evolved over four millennia. Hammurabi, who ruled Babylonia between 1850-1750 BC, compiled one of the first recorded legal codes which was based on older Summarian and Akkadian laws. Hammurabi’s system of laws codified a social order based on the rights of the individual and backed by the power of the state.
The Code of Hammurabi held physicians to a very high standard. In the code, a physician was judged by the results of his treatment and not, necessarily, by his conduct. For example, “If the doctor has treated a gentleman with a lancet of bronze and has caused the gentleman to die, or has opened the abscess of the eye of the gentleman with a bronze lancet, and has caused the loss of the gentleman’s eye, one shall cut off his hand.”1 The Code of Hammurabi is one of the earliest recorded statements of ethical practice and conduct for physicians.2
Little was known of ancient Egyptian medical practice until the end of the 19th century. A medical papyrus written about 1550 BC was found near the ancient city of Thebes in 1862. This papyrus, translated by George Moritz Ebers in 1875, has become known as the “Papyrus Ebers.” Internal evidence suggests that the papyrus, though written in 1550 BC, actually represents a collection of older medical material dating to 3000-2500 BC.
Under Egyptian rule, a physician was not held liable for an unfavorable result if he followed the accepted format for treatment of that disease.1 Diagnosis and treatment plans were outlined in sacred text attributed to Thoth, the Egyptian god-source of medical knowledge, and contained within six sacred books. The Ebers Papyrus is a compilation of remedies, recipes, prescriptions, operations and spells that served as a reference manual for physicians. Unconventional treatments not recorded in the sacred writings that resulted in the death of the patient could result in death of the treating physician.
A touchstone of modern medical ethics is the oath attributed to Hippocrates. The Oath of Hippocrates protected the rights of patients and represented principles to be practiced by physicians. The “Hippocratic Oath” was probably written in the 5th century BC by a group of Greek physicians who constituted a “school” on the island of Cos. A large body of scientific and ethical writings was produced by this school, and Hippocrates (460-375 BC) is acknowledged to have been one of its heads. Though Hippocrates certainly did not author all of the works from the school, they have been gathered together and referred to as the Corpus Hippocraticum.3
Modified extensively over the centuries, the oath attributed to Hippocrates undergirds present day medical ethics and legal practice. Today, echoes of the Hippocratic Oath can be found in the Principles of Medical Ethics developed by the American Medical Association and adopted in 1980 The preamble of the “Principles” states:
The medical profession has long subscribed to a
body of ethical statements developed primarily for
the benefit of the patient. As a member of this pro-
fession, a physician must recognize responsibility not
only to patients, but also to society, to other health
professionals, and to self. The following Principles
adopted by the American Medical Association are not
laws, but standards of conduct which define the
essentials of honorable behavior for the physician.4
I. A physician shall be dedicated to providing com-
petent medical service with compassion and
respect for human dignity.
II. A physician shall deal honestly with patients
and colleagues, and strive to expose those physi-
cians deficient in character or competence, or who
engage in fraud of deception.
III. A physician shall respect the law and also rec-
ognize a responsibility to seek changes in those
requirements which are contrary to the best inter-
ests of the patient.
IV. A physician shall respect the rights of patients, of
colleagues, and of other health professionals, and
shall safeguard patient confidences within the
constraints of the law.
V. A physician shall continue to study, apply and
advance scientific knowledge, make relevant
information available to patients, colleagues, and
the public, obtain consultation, and use the talents
of other health professionals when indicated.
VI. A physician shall, in the provision of appropriate
patient care, except in emergencies, be free to
choose whom to serve, with whom to associate,
and the environment in which to provide medical
services.
VII. A physician shall recognize a responsibility to
participate in activities contributing to an
improved community.
LAW
Law can be thought of as that collection of rules and regulations by which a society is governed. Though law is grounded in past experience, it is a dynamic concept that grows and changes, regulating social conduct in a formal and binding manner.5 The legal framework of modern western medical practice evolved from the practice of English common law.
In England, legal experience was first recorded in the fourteenth century during the reign of Edward I (1239-1307 AD). The first “year book” published during Edward’s reign was a record of the conversations and notes of lawyers regarding the legal cases of that year. Over time, these “yearbooks” accumulated a body of legal decisions and their application that served as a guideline for succeeding cases. These decisions and their application became known as “common law” and were imported to this country by English colonists.6
MALPRACTICE
Crimes are public wrongs against the state or the public at large. The “people” bring action against the perpetrator of a crime. The purpose of criminal proceedings is to protect the interest of the public and punish the offender.
Torts, in contrast, are private civil wrongs usually between individuals in which the remedy is a common law action for damages. Medical malpractice is a tort that arises from the breech of legal duty one person owes another to act reasonably in a way that will not harm another person or property.6
Malpractice is injurious or unprofessional treatment or culpable neglect of a patient by a physician or surgeon.7 Injuries, however, can occur during the course of medical treatment and may be an acceptable risk of the treatment. For malpractice to have occurred, usually one of the following must be shown by the injured patient (plaintiff):
1) Failure of the physician to follow usual practice in
the community.
2) Lack of skill.
3) Ignorance.
4) Alcohol or drug abuse.
5) Failure to tell patients of the treatment risks.
6) Lack of needed equipment, medicine or staff.
The basis of any medical malpractice suit is an assessment of fault that caused an injury to a patient. Fault centers on what is expected of a physician in the practice of medicine. Fault implies that the physician did not have the necessary amount of skill and care and, because of this lack or failure, a patient was injured. Simply put, the doctor is expected to act as a “reasonable” doctor.
To prove that malpractice has occurred, the plaintiff (injured patient) must prove to a jury four basic elements.
Duty
The Doctor - Patient relationship: The doctor must have incurred a duty to care for the patient. The obligation of a physician to care for a patient arises from establishing a doctor-patient relationship. A physician has no obligation or duty to accept a patient; however, once a doctor accepts a patient, he or she has a duty to adhere to a certain level or standard of care. The doctor-patient relationship can be established casually; a “quick” informal physical, medical prescriptions prescribed over the telephone, or the mere scheduling of an appointment may be sufficient to establish a legal doctor-patient relationship.8 Once established, this duty or obligation requires that the physician provide care for the patient.
Breach of Duty
Negligence: To prove negligence, it must be shown that the doctor didn’t conform to the standard of care. Standard care is “reasonable care” as provided by a “reasonable doctor.” The doctor must provide to a patient a level of care required under law, “the standard of care.” Standard of care may be defined as constituting the skill and care customarily exercised by doctors in the same line of practice under similar circumstances.9 This standard usually implies that physicians must possess and employ the skill and knowledge of physicians in the same and similar circumstances and with regard to the state of the profession at that time. Because of the wide availability of continuing medical education (CME) information, doctors are increasingly being held to a broad standard of care that would be acceptable nationally.
Causation
Causation suggests that the doctor didn’t conform to the standard of care and harm came to the patient. The doctor’s negligence must be the reason for or proximate cause of the injury or damage. The plaintiff (injured patient) must establish that a doctor’s breach of the standard of care proximately caused an injury. If the treatment or lack of treatment did not cause the patient’s injury, the doctor, is generally, not liable. A direct link must be proven between the alleged negligence and the harm suffered for a plaintiff to win a malpractice case.
Damages
The patient must have been injured to recover damages. Damage is the monetary compensation given to a patient for losses suffered. Mistakes without injury are usually not compensable.
Categories of damages include:
1) General damages which usually include physical
and mental disability, loss of enjoyment of life,
pain and suffering. These damages represent a
logical consequence of a particular injury.
2) Special damages are a natural result of an injury
but don’t inevitably result from it. Special dam-
ages have usually included loss of time, impair-
ment of future earning capacity, hospital, medical
and nursing expenses, the cost of drugs, aggrava-
tion of a pre-existing condition.
3) Compensatory damages refers to the money
intended to help restore the patient to the posi-
tion occupied before the injury and may include
special or general damages.
4) Punitive or exemplary damages are assessed to
punish the person sued and to deter similar con-
duct by others. These damages are in addition to
the damages assessed to compensate a person for
an injury.
Informed Consent
Informed consent is a more recent development in medical malpractice litigation having evolved over the last century.
“Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an insult for which he is liable in damages...”10 This opinion, articulated by Judge Cordoza in Schloendorf v. Society of New York Hospitals in 1914, helped establish the principle that an operation could not be performed without disclosure of its nature or scope.11 The physician was obliged to discuss the operative procedure with the patient and obtain consent to perform the procedure from the patient prior to the event.
The duty of a physician to disclose the risks of a medical procedure was more extensively explored in the 1960 case of Natanson v. Kline.12 The court in this opinion held that a physician “was obligated to make a reasonable disclosure to the appellant of the nature and probable consequences of the suggested or recommended cobalt irradiation treatment, and he was also obligated to make a reasonable disclosure of the dangers within his knowledge which was incident to, or possible in, the treatment he proposed to administer.”13 In this ruling, the physician was obligated to not only discuss details of the intervention but also was required to explore the possible risks of that intervention with the patient.
The issue of informed consent was more fully developed into its present form in the 1972 case of Canterbury v. Spence. In this court ruling, the duty to disclose all significant or material risks was outlined in absolute rather than relative terms. According to the court, all material must be disclosed regarding “the inherent and potential hazards of the proposed treatment, the alternatives to that treatment, if any, and the results likely if the patient remains untreated.”14
Informed consent requirements vary by state; however, a broad interpretation of these preceding court decisions would suggest that informed consent requires a full disclosure and discussion of the proposed medical or operative procedure, including its risks, complications, alternatives and their risks, and reasonable expectations.
Implicit in recent legal rulings is that informed consent is not a form or statement. Rather it is the process of a physician communicating with a patient about proposed treatments or procedures during the preoperative period. It is important to note that if a record of the informed consent discussion was not written into the patients chart, including a discussion of the operative procedure, its risks, complications, alternatives and their risks and reasonable expectations, legally speaking, that discussion did not occur.
LAPAROSCOPIC ISSUES
Modern laparoendoscopic surgery has introduced several new elements into the medico-legal process not present heretofore. For example, it is recognized that laparoscopic surgery is guided by electronic imaging and requires manipulation of intra-cavitary organs with instruments remote from the operative field. Additionally, the operative procedure is represented as a two-dimensional display on a video terminal and does not mimic the three-dimensional reality of everyday human experience. These factors of remote, minimally invasive, electronic image-guided surgery have changed the character of modern operative intervention.
Laparoscopic Video Imaging
Foremost of the laparoscopic elements now available to the courts has been the production of high quality video tapes recording the operative procedure. Many legal scholars consider unedited video tapes as a “disinterested observer” of the operative procedure accurately recording events in a way not possible with written documentation or human memory. For the first time, a graphic, visual record of the operative event is available to aid the physician in defense of his actions. This unimpeachable source would appear to be a perfect ally in the defense of a malpractice claim.
Reality, however, has proven somewhat different. Video tapes present a magnified view of the surgical procedure and can distort reality. Unergonomic, first generation laparoscopic instruments may appear to the untrained eye to be clumsily manipulated during “real-time” video recordings. These images are frequently magnified many times. Small bleeding arterioles can appear to be fountains of unrestrained blood loss. The focused view of the camera precludes observation of the operative field at large and may be misleading as to the actual status of the operative procedure.
Savvy plaintiff lawyers have been able to distort the information presented on laparoscopic video images and sway juries as to their content. For this reason, many laparoendoscopic surgeons do not routinely tape their operative procedures.
Other factors that mitigate against routine taping of surgical procedures include:
1) expense of tapes and taping equipment.
2) cost of storing video tape in an appropriate
environment.
3) length of time tapes must be preserved.
4) which entity, surgeon or facility, is responsible
for tape storage, maintenance and security.
Laparoscopic Learning Curve
Most general surgeons of the late 20th century were not exposed to laparoendoscopic technique during their residencies. Large numbers of established surgeons were first introduced to laparoscopy at free-standing two day post-graduate courses. Typically, these courses offered didactic presentations of laparoscopic energy sources, instruments and technique coupled with hands-on animal training.
A two day course, however, can provide only an introduction to laparoscopic instruments and procedures. It was quickly recognized that more time and experience were required to attain proficiency for “the standard of care” in laparoscopic surgery. Proficiency in operative technique requires practice, repetition and time. The time and case load to gain proficiency in a laparoscopic context has become known as the “learning curve.”
Initially, a certain minimal number of procedures was thought to assure negotiation of the learning curve. Individuals, however, varied in their capability to transition from hands-on three-dimensional surgery to two-dimensional, electronic image-guided operative technique. The learning curve was found not to be static, a “one size fits all” entity, but rather a period of time and experience that varied from individual to individual.
In the United States, each hospital or institution has the responsibility to credential a surgeon in the areas that surgeon is permitted to practice. There is general agreement that a surgeon must first be credentialled in open surgery before being considered for laparoscopic credentialling.
Adequate training for surgeons not exposed to laparoscopic surgery in a residency program requires attendance at an accredited laparoscopic course that offers both didactic presentations and hand-on animal experience. This introduction to laparoscopic methodology should be followed by experience as first-assistant to a surgeon well versed in the operative procedure.
After adequate experience as a first-assistant, the physician transitions to primary surgeon, observed and monitored by the department of surgery. A preceptor, one who is expert in the laparoscopic procedure, may be required to assist the newly trained operative surgeon during initial case work.
Finally, if deemed necessary by the department of surgery or institution governing board, a proctor may be invited to observe the surgeon and submit a report to the board as regards the operator’s technical competence.
Smaller institutions or locales may not be able to provide the experience or personnel to fulfill the above training in an even-handed manner. In these instances, failure to document adequate training can open the door to questions of not negotiating the learning curve and failure to attain the minimal standard of care necessary to perform laparoscopic procedures.
FUTURE LAPAROSCOPIC LEGAL ISSUES
Laparoscopy is a maturing field, and it is becoming evident that there are aspects of image-guided, laparoendoscopic surgery that need to be addressed. A debate is emerging as to who should perform laparoendoscopic interventional procedures. Heretofore, only those specialists trained in the surgical arts were permitted to perform interventional procedures. This practice was guided by the principle that only those practitioners who could handle all complications of an intervention should perform that intervention.
The distinction between surgeon-interventionist and nonsurgeon-interventionist, however, has blurred. Today, radiologists are beginning to examine the possibility of performing endoscopic peripheral vascular procedures under radiological guidance. Stereotactic breast biopsies and coronary angioplasty are other examples of nonsurgeon-interventionists performing procedures for which they may not be qualified to handle all of the complications of that procedure.
The legal ramifications of nonsurgeons performing interventional procedures that may require open exploration to handle complications of that intervention has not been completely addressed. It will be necessary for all parties involved in health care to examine this issue and protect the interests of the patient while maintaining fairness for all practitioners of modern, technology-driven surgery.
References
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2. Snyder JW. Hammurabi. In The World Book Encyclopedia. Chicago: World Book -Childcraft International, Inc; 1981:34.
3. Veatch RM. Medical ethics: an introduction. In Veatch RM, ed. Medical Ethics. Boston: Jones and Bartlett Publishers; 1989:1-26.
4. American Medical Association. 150th anniversary edition. Code of Medical Ethics. Current opinions with annotations. Council on Ethical and Judicial Affairs. 1996-1997 edition. Chicago: American Medical Association; 1997.
5. Kanoti GA. Ethics, medicine, and the law. In Vevaina JR, Bone RC, Kassoff E, eds. Legal Aspects of Medicine. New York: Springer-Verlag; 1989:74-81.
6. Hoffman AC. Medical malpractice. In Sanbar SS, Gibofsky A, Firestone MH, LeBlang TR, eds. Legal Medicine. 3rd edition. St Louis: Mosby; 1995:129-140.
7. Websters. New World College Dictionary. 3rd edition. Neugeldt V, Guralnik DB, eds. New York: Simon & Schuster, Inc; 1996:819.
8. Lyons v Grether, 218 Va 630, 632-4, 239 SE2d 103, 105 (1977).
9. Pike v Honsinger, 49 NE 716 (1898).
10. 211 NY at 126, 105 NE at 93 (1914).
11. 211 NY 125, 105 NE 92 (1914).
12. 186 Kan 393, 350 P2d 1093 (1960).
13. 186 Kan at 410, 350 P2d at 1106.
14. 464 F2d at 787 (DC Cir. 1972).
