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Case Summaries: Informed Consent

The Right to Informed Consent
Standards Used to Judge Informed Consent
Lack of Consent and Battery Claims
Consent and Emergencies
What Should Be Disclosed?
Conflict of Rights: Pregnant Woman vs. Fetus
Negligent Misrepresentation
Exceptions to Informed Consent

The Right to Informed Consent

Schloendorff v. Society of New York Hospital, 105 N.E. 92, 1914

This is a basic case in the bioethics literature. It contains an often quoted (in bioethics and legal literature) statement by Justice Cardozo: "Every human being of adult years and sound mind has a right to determine what shall be done with his own body…."     Top

Standards Used to Judge Informed Consent

Canterbury v. Spence, 464 F.2d 772, 1972

In this well-known case, the Court argued for a reasonable patient standard of informed consent. In doing so, the Court presented arguments against a physician-oriented standard. The case involves a boy who suffered paralysis after back surgery. He claimed that he was not adequately warned about such risks. Although recognizing that a majority of courts look to customary practices of physicians in dealing with informed consent, and that deviation from such standards may be a cause for legal action, the Canterbury Court held that informed consent depends on the individual circumstances of a patient. "In our view, the patient's right of self-decision shapes the boundaries of the duty to reveal." A physician may be held liable whenever the informed consent process unreasonably neglects what the physician should know to be the patient's informational needs.

Cobbs v. Grant, 8 Cal. 3d 229, 1972

The patient alleged that the surgeon violated his duty to obtain informed consent to surgery by failing to inform the patient of its inherent risks, many of which materialized. The Court concluded that the informational needs of the patient are paramount in obtaining informed consent. Thus, standards that emphasize the conduct of the physician are inappropriate. The legal rule that emerges from Cobbs is that a physician is under duty to disclose to a patient those risks and benefits of the proposed treatment, alternative treatments, and of no treatment, which a hypothetical reasonable patient would consider material.

Leyson v. Steuermann, 705 P.2d 37, 1985

The Court, in this Hawaiian case, surveyed a variety of issues involved in determining the standards of proper informed consent. The Court adopted a modified objective patient standard: "…we opt for the application of a modified objective standard that determines the question from the viewpoint of the actual patient acting rationally and reasonably." The Court also explicitly dealt with the four elements in a negligence claim, and states what is involved in causation: "(1) [Dr] Steuermann owed a duty to disclose to Leyson the risk of one or more of the collateral injuries that Leyson suffered; (2) Steuermann breached his duty; (3) Leyson suffered injury; and (4) Steuermann's breach of duty was a cause of Leyson's injury in that: (a) Steuermann's treatment was a substantial factor in bringing about Leyson's injury and (b) Leyson, acting rationally and reasonably, would not have undergone the treatment had he been informed of the risk of the harm that in fact occurred; and (5) no other cause is a superseding cause."

Bernard v. Char, 903 P.2d 667, 1995

This case, involving a dental procedure, found the Court rejecting a modified objective standard and instead using the objective test of causation: "…In applying the modified objective standard, the actual patient's characteristics are utilized in order to form the core viewpoint or standard from which the causation question is determined. The factfinder must then attempt to conceive from the viewpoint of the actual patient what that patient would have done had the patient been acting rationally and reasonably…. The factfinder must then attempt to engraft the characteristics of a reasonable person upon the actual patient to determine whether the patient would have consented to the medical treatment or procedure that caused his injury." The Court found this standard of determining causation too difficult to apply. The Court explained that in the objective standard, the characteristics of a given patient are applied to the core of how a reasonable patient would act.

Robinson v. Bleicher, 559 N.W.2d 473, 1997

This case provides an example of the use of a physician-based standard, that of a reasonable medical practitioner in similar circumstances. The Court stated: "In Nebraska, a physician's duty to disclose the risks of a particular procedure or treatment, allowing for informed consent, is established by the 'professional' theory. The professional theory 'holds that the duty is measured by the standard of the reasonable medical practitioner under the same or similar circumstances, and must be determined by expert medical testimony establishing the prevailing standard and the defendant practitioner's departure therefrom...." This, the Court claimed, is a locality standard and is the correct standard to be applied in this case.

Backlund v. University of Washington, 975 P.2d 950, 1999

The Court considered whether failure to provide adequate information was a cause of the patient's injury. This does not necessarily involve negligence. Treatment may be applied in a nonnegligent way and still result in an adverse outcome. If a person were informed of the risk, and rejected treatment, the harmful event would not have resulted. In this way, lack of informed consent may have caused the injury. The Court must determine whether the patient would have rejected treatment had information about risk been provided. In this case, the Court opted for an objective as opposed to a subjective standard of causation. A subjective standard involves what the given patient would have done. This is difficult to determine and may lead to false statements by the plaintiff. An objective standard was adopted (as it is in many jurisdictions) involving what a reasonable patient would have done in the patient's situation.

Catalano v. Moreland, 299 A.D.2d 881, 2002

The Court rejected using the bylaws of a hospital as a way to determine whether informed consent was proper. "Thus ... the reasonableness of defendant's conduct will be measured, not against the Hospital bylaws, but rather against what would have been disclosed by a reasonable medical practitioner. Additionally, insofar as the bylaws set forth standards of care and procedures concerning peer review and quality management, they are not discoverable."

Gouse v. Cassell, 615 A.2d 331, 1992

The Pennsylvania Supreme Court explicitly rejected the idea the patient must show that he or she would not have had the treatment had informed consent been thorough: "We hold that a physician or surgeon who fails to advise a patient of material facts, risks, complications and alternatives to surgery which a reasonable man in the patient's position would have considered significant in deciding whether to have the operation is liable for damages which ensue, and the patient need not prove that a causal relationship exists between the physician's or surgeon's failure to disclose information and the patient's consent to undergo surgery."

Rogers v. Lumbermens Mutual Casualty Company, 119 So. 2d 649, 1960

In this case, the Court rejected a blanket consent form as too ambiguous. The form read: "I hereby authorize the Physician or Physicians in charge to administer such treatment and the surgeon to have administered such anesthetics as found necessary to perform this operation which is advisable in the treatment of this patient…." The Court observed: "We think the above so-called authorization is so ambiguous as to be almost completely worthless, and, certainly, since it fails to designate the nature of the operation authorized, and for which consent was given, it can have no possible weight under the factual circumstances of the instant case."     Top

Lack of Consent and Battery Claims

Blanchard v. Kellum, 975 S.W.2d 522, 1998

A woman had all 32 of her teeth extracted during a dental visit. She claimed that she never authorized that all of her teeth would be extracted in a single visit. The extractions caused her to be hospitalized. The issue at stake is whether this case should be handled as negligence or as battery. The Court observed: "We believe that there is a distinction between: (1) cases in which a doctor performs an unauthorized procedure; and (2) cases in which the procedure is authorized but the patient claims that the doctor failed to inform the patient of any or all the risks inherent in the procedure." Furthermore, "The primary consideration in a medical battery case is simply whether the patient knew of and authorized a procedure. This determination does not require the testimony of an expert witness."

Lugenbuhl v. Dowling, 701 So.2d 447, 1986

What if a physician does not follow the treatment agreed to even though no medical damages were involved? In this case a patient was awarded damages due to a battery-like claim. A procedure that the patient explicitly rejected was used in a hernia surgery. The Court concluded that there was no evidence that the technique used caused the patient's further complications. In effect, damages stemmed from depriving the patient of the "opportunity of self-determination…." This seems to be a battery claim, so the damage award did not depend on whether the treatment itself caused further medical problems. Since this case did not involve malpractice, the Court significantly reduced the monetary award.

Chouinard v. Marjani, 575 A.2d 238, 1990

A woman with recurring breast cysts had bilateral surgery although she consented to the removal of only one breast. In informed consent cases based on negligence, the patient must show that she would not have consented had she been informed. She could not do this, but because the award was based on a battery theory, that testimony was not required.

Perna v. Pirozzi, 457 A.2d 431, 1983

The Court stated the problem at hand: "We must determine whether that substitution [of one surgeon for another], even when the two surgeons are engaged in a group practice, constitutes malpractice, a battery or both." Citing the Judicial Council of the American Medical Association, the Court concluded that in this case switching surgeons amounted to deceit, and therefore the lack of informed consent should be treated as battery.

Ashcraft v. King, 278 Cal.Rptr. 900, 1991

Surgery was performed after it was explicitly stated that only blood donated by family members should be used in any transfusion. The physician used blood from the hospital's general supply. HIV resulted. Although the operation was consented to, the plaintiff claimed battery. The Court declared: "In an action for civil battery the element of intent is satisfied if the evidence shows defendant acted with a 'willful disregard' of the plaintiff's rights." In this case, the Court found that such willful disregard occurred.

Mohr v. Williams, 104 N.W. 12, 1905

During surgery, and after consent to operate on a patient's right ear, a surgeon determined that the patient's left ear also required treatment. The treatment was successful, yet performed without consent. The Court rejected the contention that lack of damage meant that a battery did not take place: "The last contention of defendant is that the act complained of did not amount to an assault and battery. This is based upon the theory that, as plaintiff's left ear was in fact diseased, in a condition dangerous and threatening to her health, the operation was necessary, and, having been skilfully performed at a time when plaintiff had requested a like operation on the other ear, the charge of assault and battery cannot be sustained....We are unable to reach that conclusion, though the contention is not without merit. It would seem to follow from what has been said on the other features of the case that the act of defendant amounted at least to a technical assault and battery."

Duncan v. Scottsdale Med. Imaging, Ltd., 70 P.3d 435, 2003

A patient requested to know the kind of drug a nurse was administering. She was told that it was fentanyl, a synthetic drug similar to morphine. The patient rejected that drug, and asked the nurse to call the physician. The nurse subsequently told the patient that the drug was changed to morphine. The patient then consented. However, the drug was not changed, and instead the nurse administered fentanyl. A battery claim was permitted. The Court followed Cobbs v. Grant in claiming that there was a distinction between "lack of informed consent" and "lack of consent." "The battery theory should be reserved for those circumstances when a doctor performs an operation to which the patient has not consented." The Court lamented that this distinction is sometimes blurred.

Roberson v. Provident House, 576 So. 2d 992, 1991

In this Louisiana case, a nurse inserted an in-dwelling catheter over the objections of a patient. This was not an emergency situation, so the Court argued that the nurse committed a battery. The procedure was performed absent informed consent.     Top

Consent and Emergencies

Shine v. Vagas, 429 Mass. 456, 1999

The Supreme Court of Massachusetts clearly rejects the notion that in emergency situations competent persons may be treated despite their refusal of treatment. The Court considered the emergency conditions under which consent is not required based on the doctrine of presumed consent: "If, and only if, the patient is unconscious or otherwise incapable of giving consent, and either time or circumstances do not permit the physician to obtain the consent of a family member, may the physician presume that the patient, if competent, would consent to life-saving medical treatment."

Wells v. Van Nort, 100 Ohio St. 101, 1919

A woman consented to surgery to remove her appendix, but during the surgery her fallopian tubes were removed because they were found to be diseased. The Court held that the woman did not consent to have her fallopian tubes removed and that this was not an emergency situation.     Top

What Should Be Disclosed?

Harbeson v. Parke Davis, 746 F.2d 517, 1984

Disclosed risks should be related to the situation of the patient. "The crucial indicator is the 'patient's need.'" In this case, a drug taken by the mother had a negative affect on a fetus. A simple literature search would have revealed this. A reasonable patient in the situation of the woman in this case would have wanted such information.

Wachter v. United States, 689 F.Supp. 1420, 1988

Does informed consent require disclosure of physician competency? There is a tendency among courts not to require the disclosure of physician competency or incompetence. In this case, the physician's lack of skill did not result in injury. The Court held both: "(1) That the plaintiff must identify an undisclosed risk which would have altered her decision to undergo the treatment had it been disclosed; (2) That plaintiff must show that the particular risk materialized and caused injuries for which she seeks recovery." These conditions were not met in relation to the physician's competence.

Cunningham v. Charles Pfizer & Co., 1974

Some courts emphasize drug side effects as requiring disclosure, even when the risk is statistically slight. The Court, in this case, asserted that typically the responsibility to warn a patient rests with the physician, who knows the individual circumstances of the patient, and not the drug company, which should advise the physician. But in this case the drug was a vaccine, often given without a physician present. The duty thus fell to the medical society sponsoring the mass vaccination program.

Johnson v. Kokemoor, 545 N.W.2d 495, 1996

The central issue was whether performance data should be disclosed. A claim was made that the physician overstated his competence. The expected risk from a surgeon who lacked experience was much greater than the morbidity and mortality risk from the best surgeons. A reasonable person in the plaintiff's position would want to know that their chances of death or injury would be higher given the surgeon's experience. However, the Court clearly cautioned that the finding, that the risk should have been disclosed, applies to "the circumstances of this case."

Whiteside v. Lukson, 947 P.2d 1263, 1997

A surgeon failed to inform a patient about his inexperience; the surgery resulted in a damaged bile duct. Although the Court recognized that other courts require disclosure of experience, conflicts of interest, and HIV status, it claimed, in effect, that this could lead to a slippery slope, with even medical grades being required. The Court rejected disclosure of experience in performing a particular procedure as immaterial in relation to informed consent.

Behringer v. The Medical Center at Princeton, 592 A.2d. 1251, 1991

The question at issue required balancing the confidentiality of a health care professional's AIDS diagnosis against the patient's right to informed consent. The Court determined that the surgeon's risk of infecting a single patient is low, but that the risk grows with the number of patients treated. "Assuming that the surgical patient's risk is exceedingly low (1/130,000), the risk that one of his patients will contract HIV becomes more realistic the more operations he performs -- 1/1,300 (assuming 100 operations) or 1/126 (assuming 500 operations). Patients, of course, cannot expect a wholly risk-free environment in a hospital. But there does come a point where the risk of a detrimental outcome becomes sufficiently real that it is prudent for the profession to establish guidelines." The Court concluded that commitment to informed consent is strong in New Jersey, and that the patient had a right to know the risks of infection.

Hidding v. Williams, 578 So. 2d 1192, 1991

The Court in this Louisiana case stated that despite the fact that the patient signed a consent form for surgery, his right to informed consent was violated because the physician failed to disclose that he chronically abused alcohol. The Hidding Court reasoned that although the condition of the physician was not an aspect of the medical treatment itself, the reasonable patient would nevertheless want to be aware of the physician's abuse of alcohol.

Morris v. Ferriss, 669 So.2d 1316, 1996

Does a health care professional have an obligation to inform a patient about alternative treatments that are not considered to be within the appropriate standard of care? In this case, the Court concludes that this is not required: "We … conclude that the trial judge was not clearly wrong in rejecting plaintiff's assertion that she should have been advised of the alternative treatment of psychotherapy. In order to prove that psychological or psychiatric treatment was a reasonable alternative to surgery, the plaintiff had to prove that this alternative was an accepted medical treatment for her condition, which was organically based."

Truman v. Thomas, 165 Cal. Rptr. 308, 1980

In some jurisdictions, a patient must be informed about the risks of non-treatment. In this case, a physician, Dr. Thomas, did not adequately explain to the patient, Mrs. Truman, the risks involved with failure to undergo a pap smear. When a patient refuses treatment, the Court asserted that there is a duty to advise about material risks that a reasonable person would want to know. The Court based this partly on a fiduciary obligation, due to the knowledge of the physician and the lack of knowledge of the patient. "It must be remembered that Dr. Thomas was not engaged in an arms-length transaction with Mrs. Truman. Clearly … he was obligated to provide her with all the information material to her decision [not to have a pap smear]."

Moore v. PMMG, 178 Cal. App. 3d 728, 1986

The plaintiff was examined by one of the defendant's company physicians. During the examination, the physician observed a mole on the patient's ear. The physician indicated to the patient that he should see a specialist at once, since all moles are suspicious. The patient did not see a specialist. Subsequently, a biopsy disclosed that the mole was malignant melanoma. Moore suffered distortion of neck and facial features. The patient sued his physician on a Truman theory. (See Truman v.Thomas, above.) The jury awarded him $750,000 but reduced it by $250,000 for his own negligent delay in seeking treatment.

Arato v. Avedon, 858 P.2d 598, 1993

The Supreme Court of California argued that Dr. Avedon was not under a legal obligation to provide Mr. Arato, his patient, with statistical information about his cancer. Mr. Arato did not request such information, and having it, Dr. Avedon claimed, might interfere with his treatment. The Court also concluded that there is no need, in terms of informed consent, to take into account non-medical interests, such as the patient's desire to prepare for death.

Moore v. Regents of the University of California, 271 Cal.Rptr. 146, 1991

This case involved a patient with leukemia. His physician had an economic research interest in the patient's blood and bone marrow aspirate. This interest was not disclosed. The Court concluded: "A physician who adds his own research interests to this balance may be tempted to order a scientifically useful procedure or test that offers marginal, or no, benefits to the patient. The possibility that an interest extraneous to the patient's health has affected the physician's judgment is something that a reasonable patient would want to know in deciding whether to consent to a proposed course of treatment. It is material to the patient's decision and, thus, a prerequisite to informed consent."

Neade v. Portes, 237 Ill.Dec. 788, 1999

In contemporary health care arrangements, health care professionals may have a financial incentive to avoid diagnostic and treatment procedures. In this case, with little precedent, the Court struggled with the issue of whether there is a fiduciary duty to inform a patient about financial incentives. The Court supported disclosure of such financial interests, and cited the Current Opinions of the Council on Ethical and Judicial Affairs of the American Medical Association (1996-1997 edition). Section 8.132 of Current Opinions provided that patients should not be denied access to appropriate medical care based on personal financial gain or loss.     Top

Negligent Misrepresentation

Bloskas v. Murray, 646 P.2d 907, 1982

This is an interesting case because it made a distinction between a legal action based on lack of informed consent and one based on negligent misrepresentation, which is defined: "One who negligently gives false information to another is subject to liability for physical harm caused by action taken by the other in reasonable reliance upon such information, where such harm results (a) to the other, or (b) to such third persons as the actor should expect to be put in peril by the action taken. Such negligence may consist of failure to exercise reasonable care (a) in ascertaining the accuracy of the information, or (b) in the manner in which it is communicated." Even though a health care provider may have lived up to the standards involving informed consent, information may be given in a negligent way. In this case a physician told a patient not to worry about ankle replacement surgery, that in the worst case, the replacement would be removed. Instead, her ankle was amputated. The false information, the Court argued, should be considered under negligent misrepresentation.     Top

Exceptions to Informed Consent

Henderson v. Milobsky, 595 F.2d 595, 1978

In this case, involving a dental procedure, the Court argued that because informed consent is based in self-decision, a patient may freely elect to know nothing: "Physicians and courts alike must accept the patient's election to know nothing and instead to rely completely upon the physician, as well as his choice to learn everything material to a reasonably informed independent decision, for the patient…."

Harvey v. Strickland, 566 S.E.2d 529, 2002

A Jehovah's Witness explicitly rejected blood transfusions during surgery. However, while in surgery, the need arose. Since he was unconscious, the surgeon sought the consent of the patient's mother. He obtained the consent, claiming it to be an emergency. The Court disagreed because the wishes of the patient were well known.     Top

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