Law and Medicine- JLM-14-03-205

BY ADEYEMI OSHUNRINADE. {E. JD}

Outline

1. Abstract
2. Meaning of Informed Consent
3. Demand of Risk Disclosure
4. Negligence as a Cause of Action
5. Requirement of Specific Risk Information
6. Need for Statistical Mortality Information
7. Conflicts of Interests Disclosure
8. Causation
9. Remedy Issues
10. Conclusion
11. References

Abstract

The aim is to show that as in any contract, a Physician-Patient relationship is contractual and usually a prerequisite to a professional malpractice suit against a doctor. It is universally recognized that, “except in emergency or gratuitous situations, the relationship between doctor and patient is a contractual one, either expressly or by implication”, and from that premise, courts have held that, as an alternative to tort-based actions, a separate action for breach of the contract may lie when the doctor acts contradictory to a contractual undertaking, at least in some settings.[1]

Meaning of Informed Consent

The relationship that gives rise to a malpractice action is in most cases a contractual one. Due to the greater facility offered by tort-based actions for recovering damages for non-economic loss, malpractice actions have traditionally been tort-based. Unlike in a traditional negligence action, a claim for lack of informed consent focuses not on the level of skill a physician exercised in the treatment of his patient but on the adequacy of the explanation given by the physician in obtaining the patient’s consent.

Informed consent came into being out of the strong judicial recognition of individual self-determination, the belief that every person has a right of freedom from non-consensual interference with his or her person, and a basic principle that it is wrong to force another to act against his or her will.[2] “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”

The doctrine of informed consent sets boundaries for the doctor-patient relationship, through rules a physician must follow before embarking on any health related procedure on the patient. The demand is simple, a physician, must seek consent of his or her patient, and must adequately inform on the patient’s health, including pros and cons of the medical procedure as it relates to the patient’s health and well-being. For example, when a surgeon in the course of his duty, removes or operates upon an organ other than the one he and the patient agreed on, an action in battery lies, such that the physician could be sued for failing to seek consent of his patient. Likewise, a surgeon who removes the wrong kidney or amputates the wrong leg would be liable in negligence for failing to ask for consent of his patient before laying hands on her.

At the initial stage of the development of informed consent, battery provided the basis for a cause of action. The principle behind battery is to protect a patient’s physical integrity from harmful contacts and her personal dignity from unwanted bodily contact, requiring a showing only that the patient was not informed of the very nature of the medical touching.[3]

Under the doctrine of battery, the first focus is on the patient’s right to freedom from a touch different from that she consented to. Second, since the physician has a duty to inform and seek consent of his patient, the plaintiff need not prove through expert testimony what the standard of care was. All the plaintiff need do is show that the physician, failed to explain to the patient the nature and character of the particular procedure. Third, to show causation, the plaintiff must show that a touching that she never consented to occurred. Under a negligence theory, the plaintiff must prove she would have turned down the procedure if she had known all the details and risks.[4]

Case Study

Demand of Risk Disclosure

Truman v. Thomas deals with the disclosure of risks of non-treatment. The issue was whether a physician’s failure to inform his patient of the material risks of not consenting to a recommended pap smear, so that the patient might make an informed choice, may have breached the physician’s duty of due care to his patient, who died from cancer of the cervix.[5]

The court cited the rule that: A patient must be apprised not only of the “risks inherent in the procedure {prescribed, but also} the risk of a decision not to undergo the treatment, and probability of a successful outcome of the treatment.”[6]

Respondent, Dr. R. Thomas, is a family physician engaged in a general medical practice. Appellants’ mother, Rena Truman, in connection with her second pregnancy, contacted him in April 1963. He continued to act as the primary physician for Mrs. Truman and her two children until March 1969. During this six-year period, Mrs. Truman not only sought his medical advice, but also often discussed medical matters with him.

In April 1969, Mrs. Truman consulted Dr. Casey, a urologist, about a urinary tract infection that had been treated previously by Dr. Thomas. Dr. Casey discovered that she was having heavy vagina discharges and that her cervix was extremely rough. She was given prescription and advised to see a gynecologist immediately. Dr. Casey made an appointment for her with a Dr. Ritter.

In October 1969, Dr. Ritter discovered Mrs. Truman’s cervix had a cancerous tumor. Too advance for removal by surgery, the tumor was unsuccessfully treated by other methods. Mrs. Truman died in July 1970 at the age of 30. Appellants are Rena Truman’s two children and they have brought a wrongful death action against Dr. Thomas for failure to perform a Pap smear test on their mother. At trial they claimed that if Truman had undergone a pap smear at any time between 1964 and 1969, the cervical tumor probably would have been detected in time to save her life.

Although Dr. Thomas saw Mrs. Truman frequently between 1964 and 1969, he never performed the smear test on her. Dr. Thomas testified he did not “specifically” inform her on the risk involved in any failure to undergo the Pap smear test. Dr. Thomas’ medical records contain no discussion or recommendation that Mrs. Truman undergo a Pap smear test. Dr. Thomas testified that on at least two occasions when he performed pelvic examinations of Mrs. Truman, she refused him permission to perform the test, stating she could not afford it. Dr. Thomas offered to defer payments, but Mrs. Truman wanted to pay cash.

Appellants claimed failure to give a smear test proximately caused Mrs. Truman’s death. They asked the court to find Dr. Thomas liable for failure to disclose to Mrs. Truman all relevant information to enable her make an informed decision regarding the submission to or refusal to take a diagnostic test. That failure of the physician to disclose to his patient all relevant information including the risks to the patient if the test is refused, renders the physician liable for any injury legally resulting from the patient’s refusal to take the test, if a prudent person in the patient’s position would not have refused the test if adequately informed.

After motion by the defense, the jury rendered a special verdict finding Dr. Thomas free of negligence that proximately caused Mrs. Truman’s death. On appeal, the central issue was whether Dr. Thomas breached his duty of care to Mrs. Truman when he failed to inform of the potentially fatal consequences of failing to take a Pap smear test.

In its analysis of the trial court’s decision, the appellate court recognize the scope of a physician’s duty to disclose as measured by the amount of knowledge a patient needs to make an informed choice. All information material to a patient’s decision should be given. If a physician knows or should know of a patient’s unique concerns or lack of familiarity with medical procedures, this may expand the scope of required disclosure.

Citing the rule in Cobbs that a patient must be appraised not only of the “risks inherent in the procedure prescribed, but also the risk of a decision not to undergo the treatment, and the probability of a successful outcome of the patient,” the court found that the rule applies whether the procedure involves treatment or a diagnostic test. A physician recommending a risk-free procedure may forgo discussion beyond that necessary to conform to competent medical practice and to obtain the patient’s consent. However, if a patient declines the risk-free test or treatment, the physician has the extra duty of advising of all material risks of which a reasonable person would want  informed before abandoning the procedure.

Dr. Thomas contends that Cobbs does not apply to him since the duty to disclose applies where the patient consent to the recommended procedure. The court disagreed and justified its application of Cobbs since Cobbs, imposed the duty to disclose just like the case at hand so that patients, might meaningfully exercise their right to make decisions about their own bodies. The importance of this right should not be diminished by the manner in which it is exercised. The need to disclose is not lessened by a patient’s rejection of a recommended procedure. Dr. Thomas was not engaged in an arm’s-length transaction with Mrs. Truman. The physician-patient relationship between him and Mrs. Truman creates a contract by implication. Under Cobbs, Dr. Thomas was obligated to provide her with all the information material to her decision. Dr. Thomas knew that the potential harm of failing to detect the disease at an early stage was death.

Under these circumstances, a jury could reasonably find that Dr. Thomas had a duty to inform Mrs. Truman of the danger of refusing the test. It was not reasonable for him to assume that Mrs. Truman appreciated the potentially fatal consequences of her conduct.    Based on facts, the appellate court found that Dr. Thomas owed a duty to Mrs. Truman to make the disclosure.

Negligence as a cause of action

In Canterbury v. Spence, plaintiff-appellant Canterbury’s action sought damages for personal injuries sustained as a result of an operation negligently performed by Appellee Spence, Canterbury claimed Dr. Spence failed to disclose a risk of serious disability inherent in the operation, and negligent post-operative care by joint appellee Washington Hospital Center.[7] In reversing earlier judgment directed in favor of appellees, the court made clear that “true consent to what happens to one’s self is the informed exercise of choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each.”[8] Since the average patient has no understanding of the medical science and only relies on his physician for enlightenment to reach intelligent decision, there is the requirement of reasonable divulgence of information by the physician to patient, to help the patient make the best decision.

A physician is charged with a duty to treat his patient skillfully. However, his skill in diagnosis and therapy is not the full measure of his responsibility. He remains under the obligation to divulge important information to the patient as demanded under the doctrine of reasonable care. The moment a physician proceeds to treat his patient or agrees to assume the duty of caring for the patient, he is under a contract written or implied to exercise due care. This is true except in emergency or gratuitous situation.

Due care, demands that a physician perceiving symptoms of bodily abnormality must alert the patient to the condition. It may require a physician confronting an ailment that does not respond to his ministration to inform the patient thereof. A physician must instruct the patient as to any limitations observed for his own welfare, and as to any precaution and therapy the patient should seek in the future. A prudent physician has a duty to advise the patient on alternative treatment promising greater results than that pursued, and he must warn the patient of any risks to his well-being which contemplated therapy may involve.[9]

To foster its importance, informed consent has found acceptance as the norm in states and federal regulations. It is reflected in consent forms the physician must hand to his patient before beginning the procedure of treatment. Professor Alexander Capron has argued that informed consent serve six functions. It helps to: (1) protect individual autonomy; (2) avoid fraud or duress; (3) protect the patient as a human being; (4) foster rational decision-making by the patient; (5) encourage doctors to carefully consider their decision; and (6) involve the public generally in medicine.

While the followings as stated by Professor Capron are advantages the patient derive from informed consent, there are also benefits of the doctrine to the physician. A prudent physician, who properly informs his patient, will protect himself from future malpractice suit, negligence or battery charges. He is in a better position to choose the best course of treatment for the patient, since through proper information, he is likely to gain trust of the patient and gather valuable data about the patient’s state of health. The physician will help his patient cut the cost of care by abandoning unnecessary treatment thereby, gaining the patient’s confidence in his overall treatment. Also, through proper information, the physician is able to evaluate all physical and psychological impact the risk of following a course of treatment would have on the patient.

Requirement of Specific Risk Information

Johnson v. Kokemoor, emphasize on disclosure of physician specific risk information, in relation to informed consent. The bone of contention was whether the Circuit Court erred in admitting evidence that the defendant, in undertaking his duty to obtain the plaintiff’s informed consent before operating to clip an aneurysm, failed to: (1) divulge the extent of his experience in performing this type of operation; (2) compare the morbidity and mortality rates for this type of surgery among experienced and inexperienced surgeons like himself; and (3) to refer the plaintiff to a tertiary care center staffed by physicians more experienced in performing the same surgery.[10]

After reviewing the evidence submitted in the case, the Supreme Court found the Circuit Court’s ruling credible, and concluded that the three items of evidence above were material to the issue of informed consent. Citing Martin v. Richards, the court said: “A patient cannot make an informed, intelligent decision to consent to a physician’s suggested treatment unless the physician discloses what is material to the patient’s decision, i.e., all of the viable alternatives and risks of the treatment proposed.”[11] In reaching such conclusion, the court mentioned that information about a physician’s experience in performing a particular procedure, a physician’s risk statistics as compared with those of other physicians who perform that procedure, and availability of other centers and physicians better able to perform that procedure would have helped the patient in choosing a better alternative and thereby, aided her exercise of informed consent. These responsibilities upon the physician, once again prove the contractual nature of the physician obligation to his patient, especially, in cases where due diligence demands that such information be provided.

Need For Statistical Mortality Information

The limitations to a physician’s duty to disclose statistical mortality information, got tested in Arato v. Avedon, dealing with the review of a ruling by a divided Court of Appeal that, in recommending a course of chemotherapy and radiation to a patient suffering from a virulent form of cancer, the treating physicians breached their duty to obtain the patient’s informed consent by failing to disclose the statistical life expectancy, contradicting earlier ruling by the Trial Court that the defendants were not negligent in the “Medical Management” of  Mr. Arato.[12]

In reversing the Appeal’s Court decision after review of evidence, the court found that the sensitivity to context seems proper in the case of life expectancy projections for cancer patients, based on statistical samples. Testimony by every physician at the trial, confirmed that statistical morbidity value derived from the experience of population groups are inherently unreliable and provides little hope about the fate of the individual patient. “Indeed, to assume that such data are conclusive in themselves smacks of a refusal to explore treatment alternatives and the medical abdication of the patient’s well-being.”[13]

According to the Court, rather than mandate the disclosure of a specific information as a matter of law, the better rule is to instruct the jury that a physician is under a legal duty to disclose to the patient all material information that is, (relevant) “information which the physician knows or should know would be regarded as significant by a reasonable person in the patient’s position when deciding to accept or reject a recommended medical procedure,” necessary for an informed decision in the course of treatment.

The court concluded that since the standard of medical practice was not to disclose to pancreatic cancer patients specific life expectancy data, unless specifically demanded by the patient, the defendant physicians, met the standard by withholding information from Arato under the circumstances.

Conflicts of Interests Disclosure

In Moore v. Regents of the University of California, the court tested the level of disclosure of Physician conflicts of interest, in relations to informed consent. The plaintiff John Moore underwent treatment for hairy-cell leukemia at the Medical Center of the University of California at Los Angeles. The defendants were, the attending Physician Dr. David Golde, the Regents of the university of California, who own and run the university, Shirley Quan, a researcher, Genetics Institute and Sandoz Pharmaceuticals Corporation.[14]

After hospitalizing Moore and withdrawing extensive amounts of blood, bone marrow aspirate, and other bodily substances, Golde confirmed the diagnosis. On October 8, 1976, Golde recommended that Moore’s spleen be removed and informed Moore “That he had reason to fear for his life and that the proposed splenectomy operation was necessary to slow down the progress of his disease.”

Before the operation, Golde and Quan “formed the intent and made arrangements to obtain portions of Moore’s spleen following its removal” and to take them to a separate research unit. Golde gave written instructions to this effect on October 18 and 19, 1976. However, these research activities had nothing to do with Moore’s care and neither Golde nor Quan informed Moore of their plans to conduct the research or requested for his permission. Moore made other visits to the UCLA Medical Center on direction of Golde and on each of these visits Golde, withdrew more “blood, blood serum, skin, bone marrow aspirate, and sperm. Evidence show defendants exploited the exclusive access to Moore’s cells by virtue of Golde’s physician-patient relationship with Moore.

Defendants concealed all activities about the research from Moore and continued to conduct research on Moore’s cells and planned to benefit financially and competitively. Sometimes before August 1979, Golde established a cell line from Moore’s T-lymphocytes. On January 30, 1981, the Regents applied for a patent on the cell line, listing Golde and Quan as inventors. Based on policy, Regents, Golde and Quan would share the royalties or profits.

Under an agreement with Genetics Institute, Golde became a paid consultant and “acquired the rights to 75,000 shares of common stocks.” Genetics Institute also agreed to pay Golde and the Regents about $330,000 over three years and other benefits, “in exchange for exclusive access to the materials and research performed on the cell line and products derived from it. On June 4, 1982, Sandoz was added as a beneficiary in the agreement and compensation to Golde and the Regents  increased by $110,000.During the period, Quan spent 70-percent of his time working with the Regents on the cell line.

Moore alleges that Golde failed to disclose extent of his research and economic interests in Moore’s cells before obtaining consent to the medical procedure that caused his cells to be removed. The Supreme Court granted review and must decide whether Moore stated a cause of action for breach of the physician’s disclosure obligations and for conversion. The court rejected the conversion claim but found that Moore stated a cause of action as to the physician’s failure to disclose his interests.

The court based its decision on the principle that: (1) a physician must disclose personal interests unrelated to the patient’s health, whether research or economic that may affect the physician’s professional judgment; and (2) a physician’s failure to disclose such interests may give rise to a cause of action for performing medical procedure without informed consent or breach of fiduciary duty.

In its finding that Moore has stated a cause of action for lack of informed consent and breach of fiduciary duty, the court held that “a physician who is seeking a patient’s consent for a medical procedure must, in order to satisfy his fiduciary duty and to obtain the patient’s informed consent, disclose personal interests unrelated to the patient’s health, whether research or economic, that may affect his medical judgment.” The existence of a motivation for a medical procedure unrelated to the patient’s health is a potential conflict of interest and a fact material to the patient’s decision.[15]

Causation

To be actionable, there must be a causal connection between nondisclosure and injury to the patient. It is only when divulgence of significant risks incidental to treatment would have resulted in a decision by the patient not to continue with the medical procedure, can a causal connection be established. Occurrence of such risk must be harmful to the patient or else, a negligence unrelated to injury is not actionable (Canterbury). It bores down to what a prudent person in the patient’s position would have decided if properly informed of the perils that lies. If adequate divulgence of the risks or danger causing harm could have made the patient decline the medical procedure, then, causation is established.

Remedy Issues

In a situation where the medical procedure is successful as promised by the physician, and there were no alternatives to treatment but the patient, suffered an uninformed side-effect, some states apply the “benefits doctrine.” The court may consider the fact that since there were no alternatives to treatment, the operation could not have been performed without the inherent risk. The court would compare the plaintiff’s condition without the operation and her condition with the operation thereby, offsetting the complications of surgery and its benefits. “If an operation is properly performed, of overall benefit to the patient, and there are no alternative options for treatment, there should be no compensable damages awarded against the physician.”[16]

Conclusion

 Truman v. Thomas and other cases above established the fiduciary duty of care necessary in a physician-patient relationship. The big picture lies in the creation of a contractual obligation imposed on a prudent physician in his or her role as the caretaker of a patient’s health. Since patients who reject a procedure are as unskilled in the medical sciences as those who consent, it would be unconscionable to hold that patients, who reject their physician’s advice, have the responsibility of inquiring about the potential ramifications of their decisions. Such responsibility of divulgence belongs in the physician, and to so conclude, contradicts Cobbs and makes little the accepted principle that, except in emergency or gratuitous situations, the physician-patient relationship is contractual, either expressly or by implication. This general principle and its application, establish the precedent in medical malpractice cases.

References

1. Dingle v. Belin, 358 Md. 354, 749 A.2d 1571
2. Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914)
3. Jay Katz, The Silent World of Doctor and Patient 1 (1984).)
4. Kohoutek v. Hafner, 383 N.W. 2d 295 (Minn. 1986)
5. Truman v. Thomas, 27 Cal.3d 285, 165 Cal.Rptr. 308, 611 P.2d 902(1980)
6. Cobbs v. Grant, 8 Cal.3d 229, 104 Cal.Rptr 505, 502 P.2d 1 (1972).
7. Canterbury v. Spence, 464 F. 2d 772 (1972)
8. Waltz & Scheuneman, Informed Consent to Therapy, 64 Nw.U.L.Rev. 628, 629 (1970)
9. Johnson v. Kokemoor, 199 W.2d 615, 545 N.W.2d 495 (1996)
10. Martin v. Richards, 192 Wis.2d 156, 174, 531 N.W.2d 70 (1995)
11. Arato v. Avedon, 5 Cal.4^th 1172, 23 Cal.Rptr.2d 131, 858 P.2d 598 (1993)
12. Moore v. Regents of the University of California, 51 Cal.3d 120, 271 Cal.Rptr 146, 793 P.2d 479 (1990)
13. Gracia v. Meiselman, 220 N.J.Super. 317, 531 A.2d 1373 (1987)

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Categories: Academic Journal, Law and Medicine

Tags: Doctor-Patient contract, Doctor-Patient Relationship, Informed Consent, Journal of Informed Consent, Journal of Law and Medicine, Medical Malpractice, Physician-Patient Relationship, Theory of Informed Consent