[N]o right is held more sacred, or is more carefully guarded, by the common law, than the right of every individual to the possession and control of his own person.
—Union Pacific Ry. Co. v. Botsford
The reader, upon completion of this chapter, will be able to:
• Explain the difference between consent and informed consent.
• Discuss the difference between verbal, written, and implied consent.
• Describe the role of the patient, physician, nurse, and hospital in informed consent.
• Describe the theories under which the validity of consent might be proven.
• Explain how consent differs among competent patients, minors, guardians, and incompetent patients.
• Discuss under what circumstances a patient might refuse treatment.
• Explain the available defenses for defendants as it relates to informed consent.
Consent, in the healthcare setting, is the voluntary agreement by a person who possesses sufficient mental capacity to make an intelligent choice to allow a medical procedure and/or treatment proposed by another to be performed on himself or herself. Consent changes a touching that otherwise would be nonconsensual to one that is consensual. Consent can be either express or implied.
• Express consent can take the form of a verbal agreement, or it can be accomplished through the execution of a written document authorizing medical care.
• Implied consent is determined by some act or silence, which raises a presumption that consent has been authorized.
Consent must be obtained from the patient, or from a person authorized to consent on the patient’s behalf, before any medical procedure can be performed. Every individual has a right to refuse to authorize a touching. Touching of another without authorization to do so could be considered a battery. Not every touching results in a battery. When a person voluntarily enters a situation in which a reasonably prudent person would anticipate a touching (e.g., riding in an elevator or rushing through a crowded subway, emergency department), consent is implied. Consent is not required for the normal, routine, everyday touching and bumping that occurs in life. In the process of caring for patients, it is inevitable that they will be touched. Most touching in the healthcare setting is considered routine. Typical routine touching includes bathing, administering medications, dressing changes, and so forth. This chapter reviews the many issues surrounding consent.
13.1 INFORMED CONSENT
Informed consent is a legal doctrine that provides that a patient has the right to know the potential risks, benefits, and alternatives of a proposed procedure. Canterbury v. Spence, in 1972, set the “reasonable man” standard, which required informed consent for treatment. Patients must be informed of the risks, benefits, and alternatives associated with recommended treatments. Where there are two or more medically acceptable treatment options, the competent patient has the absolute right to know about and select from the available treatment options after being informed of the risks, benefits, and alternatives of each.
The informed consent doctrine provides that a physician has a legal, ethical, and moral duty to respect patient autonomy and to provide only such medical care as authorized by the patient. An authorization from a patient who does not understand to what he or she is consenting is not effective consent.
The right to be free from unwanted medical treatment has long been recognized by the courts. The right to control the integrity of one’s own body spawned the doctrine of informed consent. The U.S. Supreme Court, in Cruzan v. Director, Missouri Dep’t of Health, held that a competent adult patient has the right to decline any and all forms of medical intervention, including lifesaving or life-prolonging treatment.
Verbal consent, if proved, is as binding as written consent because there is, in general, no legal requirement that a patient’s consent be in writing. However, oral consent is more difficult to corroborate.
Verbal Consent for Surgery Adequate
The plaintiff in Siliezar v. East Jefferson General Hospital argued that the defendants breached the standard of care by failing to obtain written consent for a surgical procedure. The trial judge found that the plaintiff failed to sustain her burden of proof that the defendants were liable to her for damages. On appeal, the appellees admitted that they breached hospital policy by failing to obtain written consent prior to surgery. The physician testified that he explained the surgical procedure, as well as the risks of the procedure. He testified that after he explained the procedure and its risks, he left a written consent for the patient to sign. He explained that although it is the policy of the clinic to obtain a written consent prior to performing surgery, the patient did not sign the consent form. The surgeon testified that he did not know why the form was not signed but that the patient did not refuse to sign the form.
At trial, a nurse testified that she placed the patient in an operating room and prepared her for surgery. Although she was not in the room when the surgeon discussed the surgical procedure with the plaintiff, she testified that she was in the next room and was able to hear the physician explain the procedure to the plaintiff. The nurse also had no explanation as to why the consent was not signed. She did state that the patient never said she did not want surgery and did not ask the physician to stop the procedure. The nurse testified that as the physician performed the surgery, he explained to the patient what he was doing.
Louisiana statutes do not require that a patient’s consent be written. Verbal consent was sufficient. The verbal consent included the information required by statute, and the patient was given an opportunity to ask questions and those questions were answered. The plaintiff claimed that she was told that surgery would not be performed. The trial judge did not find her testimony to be credible. The appellate court found that the defendants did not commit malpractice by failing to obtain written consent prior to surgery.
A written consent form should be executed when a proposed treatment may involve some unusual risk(s) to the patient. A written consent provides visible proof of a patient’s wishes. Because the function of a written consent form is to preserve evidence of informed consent, the nature of the treatment, the risks, the benefits, and the consequences involved should be incorporated into the consent form. States have taken the view that consent, to be effective, must be informed consent and should include the following elements:
• Nature of the patient’s illness or injury
• Procedure or treatment consented to
• Purpose of the proposed treatment
• Risks and probable consequences of the proposed treatment
• Probability that the proposed treatment will be successful
• Alternative methods of treatment and their associated risks and benefits
• Risks and prognosis if no treatment is rendered
• An indication that the patient understands the nature of any proposed treatment, the alternatives, the risks involved, and the probable consequences of the proposed treatment
• Signatures of the patient, physician, and witnesses
• Date the consent is signed
Healthcare professionals have an important role in the realm of informed consent. They can be instrumental in averting major lawsuits by being observant as to the doubts, changes of mind, confusion, or misunderstandings expressed by a patient regarding any proposed procedures he or she is about to undergo.
Although the law requires consent for the intentional touching that stems from medical or surgical procedures, exceptions do exist with respect to emergency situations. Implied consent will generally be presumed when immediate action is required to prevent death or permanent impairment of a patient’s health. If it is impossible in an emergency to obtain the consent of the patient or someone legally authorized to give consent, the required procedure may be undertaken without liability for failure to procure consent.
Unconscious patients are presumed under law to approve treatment that appears to be necessary. It is assumed that such patients would have consented if they were conscious and competent. However, if a conscious patient expressly refuses to consent to certain treatment, such treatment may not be instituted after the patient becomes unconscious. Similarly, conscious patients suffering from emergency conditions retain the right to refuse consent.
If a procedure is necessary to protect one’s life or health, every effort must be made to document the medical necessity for proceeding with medical treatment without consent. It must be shown that the emergency situation constituted an immediate threat to life or health.
In Luka v. Lowrie, a case involving a 15-year-old boy whose left foot had been run over and crushed by a train, consultation by the treating physician with other physicians was an important factor in determining the outcome of the case. On the boy’s arrival at the hospital, the defending physician and four house surgeons decided it was necessary to amputate the foot. The court said it was inconceivable that, had the parents been present, they would have refused consent in the face of a determination by five physicians that amputation would save the boy’s life. Thus, despite testimony at the trial that the amputation may not have been necessary, professional consultation before the operation supported the assertion that a genuine emergency existed and consent could be implied.
Consent also can be implied in nonemergency situations. For example, a patient may voluntarily submit to a procedure, implying consent, without any explicitly spoken or written expression of consent. In the Massachusetts case of O’Brien v. Cunard Steam Ship Co., a ship’s passenger who joined a line of people receiving injections was held to have implied his consent to a vaccination. The rationale for this decision is that individuals who observe a line of people and who notice that injections are being administered to those at the head of the line should expect that if they join and remain in the line, they would receive an injection. The plaintiff entered the line voluntarily. The plaintiff had opportunity to see what was taking place at the head of the line and could have exited the line, but chose not to do so. The jury appropriately determined this to be consent to the injection. The O’Brien case contains all of the elements necessary to imply consent to a voluntary act: the procedure was a simple vaccination, the proceedings were visible at all times, and the plaintiff was free to withdraw up to the instant of the injection.
Whether a patient’s consent can be implied is frequently asked when the condition of a patient requires some deviation from an agreed-on procedure. If a patient expressly prohibits a specific medical or surgical procedure, consent to the procedure cannot be implied. The same consent rule applies if a patient expressly prohibits a particular extension of a procedure, even though the patient voluntarily submitted to the original procedure.
Many states have adopted legislation concerning emergency care. An emergency in most states eliminates the need for consent. When a patient is clinically unable to give consent to a lifesaving emergency treatment, the law implies consent on the presumption that a reasonable person would consent to lifesaving medical intervention.
When an emergency situation does arise, there may be little opportunity to contact the attending physician, much less a consultant. The patient’s records, therefore, must be complete with respect to the description of his or her illness and condition, the attempts made to contact the physician as well as relatives, and the emergency measures taken and procedures performed. If time does not permit a court order to be obtained, a second medical opinion, when practicable, is advisable.
Judicial consent may be necessary in those instances where there is concern as to the absence or legality of consent. Judicial intervention is periodically necessary to grant consent on an emergency basis when a court is not in session. A judge should be contacted only after alternative methods have been exhausted and the matter cannot wait for a determination during the normal working hours of the court. Some courts (e.g., Massachusetts trial courts) require an attorney to initiate the call to the justice and to certify that there are no alternatives, other than a judicial response, available in the matter.
13.2 PHYSICIANS AND INFORMED CONSENT
Informed consent is predicated on the duty of the physician to disclose to the patient sufficient information to enable the patient to evaluate a proposed medical or surgical procedure before submitting to it. Informed consent requires that a patient have a full understanding of that to which he or she has consented. A physician’s explanation of treatment options should take into consideration the patient’s ability to understand the description of the risks of treatment and the probable consequences of each treatment. The needs of each patient can vary depending on age, maturity, and mental status.
Informed consent should include what a reasonable person would consider material to his or her decision of whether or not to undergo treatment. Florida statute § 766.103 (3) (a) (2) notes that reasonable care on the part of a physician in obtaining informed consent for treatment consists of providing the patient with information sufficient to give a reasonable person a general understanding of the proposed procedure, the medically acceptable alternative procedures, and the substantial risks and hazards inherent in the proposed procedure that are recognized by other physicians in the same or similar community who perform similar procedures. A physician is not under a duty to elucidate upon all the possible risks, but only those of a serious nature. Expert testimony is required to establish whether a reasonable physician in the community would make the pertinent disclosures under the same or similar circumstances.
The ethical rationale underlying the doctrine of informed consent is firmly rooted in the notions of liberty and individual autonomy. Informed consent protects the basic right of the patient to make the ultimate informed decision regarding the course of treatment to which he knowledgeably consents. The focus of informed consent must involve the patient receiving informed consent as a result of active personal interaction with the physician. Consent forms should be used as a supplement to the oral disclosure of risks, benefits, and alternatives to the proposed procedure that a physician normally gives. Ideally, the consent should be the result of an active process of dialogue between the patient and physician.
Unreported Robot Surgery Injuries Open New Questions for FDA
When Sheena Wilson, 45, underwent robotic surgery for a hysterectomy in May, she didn’t know the Intuitive Surgical Inc. system used by her doctor was previously tied to a variety of injuries for the same procedure.
Her rectum was badly burned in the operation, said Wilson, a mother of two from Parlin, New Jersey. Now she is on long-term disability, fearful of losing her job and facing a third corrective surgery, she said in a telephone interview.
“If I had known there were other people who had injuries, I would never have done this surgery,” said Wilson, who has filed suit against Intuitive and her doctor. “Whatever they have in place is not working.”
—Robert Langreth, Bloomberg, December 30, 2013
Informed consent is not merely a tool to avoid lawsuits; rather, it is designed to allow patients to make an informed decision. The emphasis on informed must not be to avoid a lawsuit by meeting some legal requirement, with little regard to the patient’s level of understanding. The use of consent forms in this manner has contributed to the view that what was intended as a process of dialogue and discussion has developed into an event in which papers are signed and minimal legal requirements are satisfied. The consent form is often used as a legal protection for the physician for unforeseen mishaps that might occur during surgery.
Physicians Must Disclose Alternatives
The patient-plaintiff in Stover v. Surgeons suffered damage to her heart valves as a result of childhood rheumatic fever. Dr. Ford, one of a group of physicians that the patient consulted after her condition worsened, informed the patient she needed a heart valve replacement. Dr. Ford stated that he briefly reviewed the details of the surgery with the patient. The plaintiff claims she was never informed about the risks associated with installing mechanical valves, including the Beall valve that was implanted in her. Thromboemboli, strokes, and the lifelong use of anticoagulants, which are common adverse effects of valve replacements, were never discussed with her. Dr. Zikria, who performed the surgery, could not recall discussing any risks, other than clotting. Following surgery, the patient suffered severe, permanent brain damage from multiple episodes of thromboemboli directly caused by valve implantation. She then sued for lack of informed consent. The jury returned a verdict for her and the physicians appealed. The Pennsylvania Superior Court held that the physicians had to discuss alternative prostheses with the patient where they represented medically recognized alternatives. Evidence that the heart valve actually implanted was no longer in general use at the time of operation was relevant and material to the issue of informed consent. The court reasoned that alternative valves were available and never discussed with the patient. Although the physicians argued that the choice of prosthesis should belong to them, the court held that if there are other recognized, medically sound alternatives, the patient must be informed about the risks and benefits of them in order to make a sound judgment regarding treatment, including the desire to execute a waiver of consent. The agreement between the physician and the patient is contractual. Consent is not valid if the patient does not understand the operation to be performed and its seriousness. Here the physicians failed to inform the patient about the recognized risks of the valve implanted.
The patient-plaintiff in Matthies v. Mastromonaco, an elderly woman living alone in a senior citizens’ residence, fell and fractured her hip and was taken to the hospital. An orthopedic surgeon, the defendant, reviewed the patient’s history, condition, and X-rays and decided that, rather than using a pinning procedure for her hip involving the insertion of four steel screws, it would be better to adopt a conservative course of treatment, bed rest.
Prior to her injury, the plaintiff maintained an independent style of living. She did her own grocery shopping and other household duties and had been able to climb steps unassisted.
Expert testimony at trial indicated that bed rest was an inappropriate treatment. The defendant was of the opinion that given the frail condition of the patient and her age, she would be best treated in a nursing home and, therefore, opted for a more conservative treatment. At the heart of the informed consent issue was the plaintiff’s assertion that she would not have consented to bed rest if she had been informed of the probable effect on the quality of her life.
The New Jersey Supreme Court held that it is necessary to advise a patient when considering alternative courses of treatment. The physician should have explained medically reasonable invasive and noninvasive alternatives, including the risks and likely outcomes of those alternatives, even when the chosen course is noninvasive.
In an informed consent analysis, the decisive factor is not whether a treatment alternative is invasive or noninvasive, but whether the physician adequately presents the material facts so that the patient can make an informed decision. That conclusion does not imply that a physician must explain in detail all treatment options in every case. The standard obligates the physician to disclose only that information material to a reasonable patient’s informed decision. If the patient’s choice is not consistent with the physician’s recommendation, the physician has the option of withdrawing from the case. The patient, then, has the option to seek another physician who is comfortable with the alternative treatment preferred by the patient.
PHYSICIAN’S DUTY TO ADVISE: DELICATE MEDICAL JUDGMENT
Citation: Mathias v. St. Catherine’s Hosp., Inc., 569 N.W.2d 330 (Wis. App. 1997)
Mathias, a patient of Dr. Witt’s at St. Catherine’s Hospital, delivered a full-term son by cesarean section on February 2, 1993, while she was under general anesthesia. In the operating room, Dr. Witt indicated that he needed a particular instrument that would be used in a tubal ligation. The nurses, Ms. Snyder and Ms. Perri, employees of St. Catherine’s, looked at Mathias’s chart. Ms. Snyder informed Dr. Witt that she could not find a signed consent form for the procedure. In deposition testimony, Ms. Snyder stated that Witt replied, “Oh, okay.”
Dr. Witt performed a tubal ligation. Three days after the procedure a nurse brought Mathias a consent form that had to be signed, telling Mathias the form was “just to close up our records.” The nurse testified in her deposition that she signed Ms. Perri’s name on that same consent form and backdated it to February 2, the day the surgery was performed. The trial court noted that these actions after the surgery were immaterial to the issue of the hospital’s duty to Mathias. The trial court granted summary judgment dismissing St. Catherine’s from the malpractice action. Mr. and Ms. Mathias appealed the summary judgment, contending that the hospital owed a duty to Mathias to prevent her physician from performing a tubal ligation for which there was no signed consent.
Did the hospital owe a duty to Mathias to prevent her physician from performing a tubal ligation for which there was no consent? Did the trial court err in granting summary judgment to St. Catherine’s?
The trial court’s grant of summary judgment was affirmed.
The duty to advise a patient of the risks of treatment lies with the physician and not the hospital. This duty is codified in Wisconsin Statute § 448.30, which requires the following:
Any physician who treats a patient shall inform the patient about the availability of all alternate, viable medical modes of treatment and about the benefits and risks of these treatments. The physician’s duty to inform the patient under this section does not require disclosure of:
1. information beyond what a reasonably well qualified physician in a similar medical classification would know
2. detailed technical information that in all probability a patient would not understand
3. risks apparent or known to the patient
4. extremely remote possibilities that might falsely or detrimentally alarm the patient
5. information in emergencies where failure to provide treatment would be more harmful to the patient than treatment
6. information in cases where the patient is incapable of consenting
This statute is the cornerstone of the hospital’s duty in this case. The court noted that the legislature limited the application of the duty to obtain informed consent to the treating physician. The Mathiases sought to extend the duty of ensuring informed consent to the hospital.
The duty to inform rests with the physician and requires the exercise of delicate medical judgment. It is the physician—not the hospital—who has the duty to obtain informed consent. The surgeon, not the hospital, has the education, training, and experience necessary to advise each patient of the risks associated with a proposed procedure. The physician is in the best position to know the patient’s medical history and to evaluate and explain the risks of treatment options.
1. Do you agree with the court’s finding that the hospital had no legal duty to ensure that Witt obtain informed consent from Mathias? Explain.
2. What issues do you see in another nurse’s decision to sign Perri’s name on the consent form and then backdate it to February 2, 1993?
Adequacy of Consent
When questions arise as to whether the risks, benefits, and alternatives to treatment are adequate, the courts require that physicians reveal to their patients the information that skilled physicians of good standing would provide under the same or similar circumstance. The plaintiff in Ramos v. Pyati had injured his thumb while at work. The plaintiff was diagnosed as having a ruptured thumb tendon. The plaintiff consented to a surgical repair of the thumb. During surgery, the defendant discovered that scar tissue had formed, causing the ends of the tendons in the thumb to retract. As a result, the surgeon decided to use a donor tendon to make the necessary repairs to the thumb. He chose a tendon from the ring finger. On discovering additional disability from the surgery, the plaintiff filed a suit alleging that his hand was rendered unusable for his employment as a mechanic and that the defendant had breached his duty by not advising him of the serious nature of the operation, by not exercising the proper degree of care in performing the operation, and by failing to discontinue surgery when he knew or should have known that the required surgery would most likely cause a greater disability than the already injured condition of the thumb. The plaintiff testified that although he signed a written consent form authorizing surgery on his thumb, he did not consent to a graft of his ring finger tendon or any other tendon. The plaintiff’s expert witness testified that the ring finger is the last choice of four other tendons that could have been selected for the surgery. The circuit court entered a judgment for the plaintiff, and the defendant appealed. The appellate court upheld the judgment for the plaintiff, finding that the plaintiff had not consented to use of the ring finger tendon for repair of the thumb tendon.
Lack of Consent
Four children, in Riser v. American Medical Intern, Inc., brought a medical malpractice action against Lang, a physician who performed a femoral arteriogram on their 69-year-old mother, Riser, who subsequently died of a stroke 11 days following the procedure. Riser had been admitted to De La Ronde Hospital experiencing impaired circulation in her lower arms and hands. The patient had multiple medical diagnoses, including diabetes mellitus, end stage renal failure, and arteriosclerosis. Her physician, Dr. Sottiurai, ordered bilateral arteriograms to determine the cause of the patient’s impaired circulation. Because De La Ronde Hospital could not accommodate Sottiurai’s request, Riser was transferred to Dr. Lang, a radiologist at St. Jude Hospital. Dr. Lang performed a femoral arteriogram, not the bilateral brachial arteriogram ordered by Sottiurai. The procedure seemed to go well, and the patient was prepared for transfer back to De La Ronde Hospital. However, shortly after the ambulance departed the hospital, the patient suffered a seizure in the ambulance and was returned to St. Jude. Riser’s condition deteriorated, and she died 11 days later. The plaintiffs claimed in their lawsuit that Riser was a poor risk for the procedure.
The district court ruled for the plaintiffs and Dr. Lang appealed. On appeal, the Louisiana Court of Appeal found no error in the trial court’s decision. Testimony revealed that Dr. Lang breached the standard of care by performing a procedure that he knew or should have known would have had no practical benefit to the patient or her referring physician.
As to informed consent, a reasonably prudent person in the position of Riser would have refused to undergo the procedure if he or she had known of the strong possibility of a stroke. Informed consent requires that the physician reveal to the patient all material risks. The consent form itself did not contain express authorization for Dr. Lang to perform the femoral arteriogram. Sottiurai ordered a brachial arteriogram, not a femoral arteriogram. Two consent forms were signed; neither form authorized the performance of a femoral arteriogram. O’Neil, one of Riser’s daughters, claimed that, following the arteriogram, her mother said, “Why did you let them do that to me?”
Although Dr. Lang claims that he explained the procedure to Riser and O’Neil, the trial court, faced with this conflicting testimony, chose to believe the plaintiffs. The defendants argued that the plaintiffs had not established a causal connection between the arteriogram and the stroke. There was conflicting testimony between the pathologists who testified at trial as to the cause of the patient’s death. The judge chose to believe the pathologist’s testimony that it was more probable than not that the stroke resulted from the arteriogram performed by Dr. Lang.
13.3 HOSPITALS AND INFORMED CONSENT
Hospitals generally do not have an independent duty to obtain informed consent or to warn patients of the risks of a procedure to be performed by a physician who is not an agent of the hospital. It is the treating physician who has the education, expertise, skill, and training necessary to treat a patient and determine what information a patient should have in order to give informed consent. Hospital employees do not normally possess the knowledge of a particular patient’s medical history, diagnosis, or other circumstances that would enable the employee to fully disclose all pertinent information to the patient. Ohio Revised Code, for example, provides:
2317.54 Informed consent to surgical or medical procedure or course of procedures.
No hospital, home health agency, ambulatory surgical facility, or provider of a hospice care program or pediatric respite care program shall be held liable for a physician’s failure to obtain an informed consent from the physician’s patient prior to a surgical or medical procedure or course of procedures, unless the physician is an employee of the hospital, home health agency, ambulatory surgical facility, or provider of a hospice care program or pediatric respite care program.
Although hospitals do not generally have responsibility of providing patients with informed consent, there are cases where hospitals have been found to owe a duty to provide patients with informed consent. For example, the patient-plaintiff, Keel, in Keel v. St. Elizabeth Medical Center, Ky., filed a medical malpractice action alleging that the hospital failed to provide him with informed consent when he went there for a computed tomography (CT) scan. The scan involved the injection of a contrast dye material. Prior to the test, Keel was given no information concerning any risks attendant to the procedure. The dye was injected, and the scan was conducted. However, the plaintiff developed a thrombophlebitis at the site of the injection.
The plaintiff argued that expert medical testimony was not required in order to prove the absence of informed consent. The hospital argued that the question of informed consent, like the question of negligence, must be determined against the standard of practice among members of the medical profession.
The circuit court granted summary judgment to the hospital on the grounds that the plaintiff failed to present expert testimony on the issue. The plaintiff appealed.
The Kentucky Supreme Court held that expert testimony was not required to establish lack of informed consent and that the hospital had a duty to inform the patient of the risks associated with the procedure. In view of the special circumstances of this case, the court found it significant that the hospital offered Keel no information whatsoever concerning any possible hazards of this particular procedure, while at the same time the hospital admits that it routinely questions every patient about to undergo a dye injection as to whether he or she has had any previous reactions to contrast materials. The questions to patients regarding reactions to CT scans demonstrated that the hospital recognized the substantial possibility of complications. The inconsistencies here were found to be apparent without the need for expert testimony.
Life or Death: Right to Choose
Vega, a Jehovah’s Witness, in Stamford Hospital v. Nelly E. Vega, executed a release requesting that no blood or its derivatives be administered to her during her hospitalization. Vega’s husband also signed the release. She delivered a healthy baby. Following the delivery, Vega bled heavily. Her obstetrician, Dr. Sood, recommended a dilation and curettage (D&C) to stop the bleeding. Although Vega agreed to permit Dr. Sood to perform the D&C, she refused to allow a blood transfusion.
Vega’s condition continued to worsen. Eventually, when she was having difficulty breathing, her physicians placed her on a respirator in the intensive care unit. Because Dr. Sood and other physicians involved in Vega’s care believed that it was essential that she receive blood in order to survive, the hospital filed a complaint requesting that the court issue an injunction that would permit the hospital to administer blood transfusions. The trial court convened an emergency hearing at the hospital. Vega’s physicians testified that, with reasonable medical certainty, she would die without blood transfusions. Her husband testified that, on the basis of his religious beliefs as a Jehovah’s Witness, he continued to support his wife’s decision to refuse transfusions. The court, relying on the state’s interests in preserving life and protecting innocent third parties and noting that Vega’s life could be saved by a blood transfusion, granted the hospital’s request for an injunction permitting it to administer blood transfusions. Vega recovered and was discharged from the hospital.
The Connecticut Supreme Court determined that the hospital had no common law right or obligation to thrust unwanted medical care on a patient who, having been sufficiently informed of the consequences, competently and clearly declined that care. The hospital’s interests were sufficiently protected by Vega’s informed choice, and it was not for the court to override that choice. Vega’s common-law right of bodily self-determination was entitled to respect and protection. The trial court improperly issued an injunction that permitted the hospital to administer blood transfusions to Vega. The question as to state interests in saving the life of a healthy mother and child was left for another day. Justice J. Palmer, in a concurring opinion, stated, “By declining the opportunity to address the issue of the state’s interest in such a case, we leave unanswered—without good cause, in my judgment—a question that is central to the fundamental issue presented by this appeal and one that was raised both in the trial court and on appeal.”
13.4 NURSES AND INFORMED CONSENT
In general, a nurse has no duty to advise a patient as to a particular procedure to be employed; advise the patient as to the risks, benefits, and alternatives to a recommended procedure; or obtain a patient’s informed consent prior to surgery merely because the physician directed a nurse to have the patient sign a consent form.
The plaintiff, Davis, in Davis v. Hoffman, experienced pain in her lower abdomen and consulted Dr. Hoffman. He diagnosed her to be suffering from a fibroid uterus and prescribed a D&C procedure designed to remove the fibroids. Hoffman further suggested a laparoscopy and hysteroscopy to search for cancer. The plaintiff claimed that she specifically informed Hoffman and Puchini (the doctor’s nurse) that she did not consent to a hysterectomy. They responded that they would awaken her during the operation to obtain her consent before proceeding to a hysterectomy. The plaintiff underwent a procedure that resulted in a hysterectomy, during which no one awakened Davis to discuss and explore possible alternatives. The plaintiff brought an action for lack of informed consent against Hoffman, Puchini, and the hospital.
In response to the plaintiff’s allegation that the hospital committed battery by lack of informed consent to the hysterectomy, the hospital asserted that Pennsylvania law places no duty on a hospital to obtain a patient’s consent to an operation. The hospital argued that Pennsylvania courts have applied the doctrine of informed consent only to physicians, not to hospitals. The plaintiff responded that the hospital gratuitously undertook to obtain her consent prior to the operation. Although the consent form authored and printed by the hospital was used, there was no suggestion that the deficiency in consent was in any way causally inadequate in the form. Rather, any failure was attributed to the omissions in the way the form was filled in or in the way the patient was not informed as to the next phase of the operation. Thus, the form was causally irrelevant and could not be a basis for finding liability.
Because nurses do not have a duty to obtain informed consent in Pennsylvania, the plaintiff had not stated a claim for battery by lack of informed consent against Puchini. Pennsylvania law generally imposes no duty on persons other than surgeons to obtain informed consent prior to surgery.
13.5 VALIDITY OF CONSENT
Some courts have recognized that the condition of a patient may be taken into account to determine whether the patient has received sufficient information to give consent. The individual responsible for obtaining consent must weigh the importance of giving full disclosure to the patient against the likelihood that such disclosure will seriously and adversely affect the condition of the patient.
The courts generally use a “subjective” or “objective” test to determine whether a patient would have refused treatment if the physician had provided adequate information as to the risks, benefits, and alternatives of the procedure. Under the subjective test theory, the court examines whether the “individual patient” would have chosen the procedure if he or she had been fully informed. In the objective test, the plaintiff must prove that a “reasonable person” would not have undergone the procedure if he or she had been properly informed. As described in the following cases, the courts favor the objective test.
The subjective standard relies solely on the patient’s testimony. Patients must show that they would not have consented to the procedure(s) had they been advised of the particular risk in question. Proponents of the subjective standard argue that a patient should have the right to make medical decisions regarding his or her care regardless of whether the determination is rational or reasonable. The subjective standard, however, potentially places the physician in jeopardy of the patient’s hindsight and bitterness. The subjective standard is premised on the credibility of a patient’s testimony.
When applying the objective standard, the finder of fact may take into account the characteristics of the plaintiff, including the plaintiff’s idiosyncrasies, fears, age, medical condition, and religious beliefs. Accordingly, the objective standard affords the ease of applying a uniform standard and yet maintains the flexibility of allowing the finder of fact to make appropriate adjustments to accommodate the individual characteristics and idiosyncrasies of an individual patient. The standard to be applied in informed consent cases is whether a reasonable person in the patient’s position would have consented to a procedure or treatment in question if adequately informed of all significant perils. Under the objective analysis, the plaintiff’s testimony is only one factor when determining the issue of informed consent. The issue is not whether a particular patient would have chosen a different course of treatment; the issue is whether a reasonable patient would have chosen a different course of treatment.
Warren, in Warren v. Schecter, was diagnosed as having a stomach ulcer. Dr. Schecter recommended surgery to remove the portions of the stomach containing the ulcer. One of the significant risks of gastric surgery is decreased calcium absorption, leading to early and severe metabolic bone disease. It was Dr. Schecter’s role as the surgeon to advise Warren of the risks of surgery in order to obtain informed consent. Although he did not discuss these risks with her, he did advise Warren that she might experience bowel obstructions, dumping syndrome involving nausea, and the slight risk of death from anesthesia. Based on the risks disclosed to Warren, she consented to the surgery, which Dr. Schecter performed.
Following surgery, Warren developed dumping syndrome, a side effect that occurs in approximately 1% of the patients who undergo this procedure. Warren returned to Dr. Schecter, who recommended a second surgery to relieve the pain and discomfort from the first surgery. The second surgery would enhance the risk of bone disease. However, Dr. Schecter again failed to advise Warren of the risk of metabolic bone disease. Warren was eventually taken to a hospital emergency department where she was advised that she had suffered a fracture of one of her lumbar vertebrae and that previous surgeries led to osteoporosis that resulted in a fracture.
Warren filed an action for medical negligence, alleging that Dr. Schecter was liable under an informed consent theory for performing surgery without advising her of the risk of metabolic bone disease. Warren claimed that had Dr. Schecter warned her of the risk of metabolic bone disease, she would not have consented to surgery. The jury decided that: (1) Dr. Schecter did not disclose to Warren all relevant information that would enable her to make an informed decision regarding surgery; (2) a reasonably prudent person in Warren’s position would not have consented to surgery if adequately informed of all the significant perils; and (3) Dr. Schecter’s negligence was a cause of injury to Warren.
On appeal, the plaintiff was found entitled to compensation for all damages proximately resulting from the physician’s failure to give full disclosure of the risks of surgery. The patient was entitled to recover because she would not have consented to any surgery had the true risk been disclosed. A plaintiff meets the burden of establishing a causal relationship between the physician’s failure to inform and the injury to the plaintiff by demonstrating that a prudent person in the plaintiff’s position would have declined the procedure if adequately informed of the risks. Under the objective standard, Warren had only to prove that a prudent person in her position would not have consented if adequately informed of the risks. Dr. Schecter failed to provide Warren with the risks and benefits of the surgical procedures prior to obtaining her consent for the operations.
OBJECTIVE TEST PREFERRED
Citation: Ashe v. Radiation Oncology Assocs., 9 S.W.3d 119 (Tenn. 1999)
Ashe underwent a double mastectomy and chemotherapy in 1988. By 1993, she began experiencing problems with a cough and a fever. She returned to her oncologist, Dr. Kuzu, where she presented a variety of symptoms, including fever, cough, weight loss, and decreased appetite. A chest X-ray and a CT scan revealed the presence of a mass in her left lung.
Ashe underwent surgery, and the upper portion of her left lung was removed. She underwent chemotherapy and was referred to the defendant, Dr. Stroup, who prescribed radiation treatment. Ashe agreed to radiation treatment and was later diagnosed with radiation myelitis caused by a permanent radiation injury to her spinal cord. She is now a paraplegic. Dr. Stroup did not inform Ashe that the radiation treatment might result in a permanent injury to her spinal cord.
Ashe filed an action alleging claims for medical malpractice and lack of informed consent. Dr. Perez, Ashe’s expert, testified that the risk of spinal cord injury was 1% to 2%. Perez testified that the applicable standard of care required physicians to warn patients about the risk of radiation injury to the spinal cord. Ashe testified that she would not have consented to radiation therapy had she been informed of the risk of paralysis. On cross-examination, defense counsel pointed out that the plaintiff did equivocate in her deposition on the issue of consent. Her deposition testimony indicated that she did not know what she would have done had she been warned about the risk of spinal cord injury. She then testified on redirect examination that if Dr. Stroup had said to her, “‘Patty, if you do this, there is a risk that you will be in a wheelchair six months from now,’ I would have told him, ‘I will take my chances.’ I would not have it done.”
The trial court found that the plaintiff’s trial testimony conflicted with her deposition testimony regarding whether she would have consented to the procedure had she been warned of the risk of spinal cord injury. The trial court, therefore, struck the trial testimony and granted the defendant a directed verdict on the informed consent claim. The plaintiff’s malpractice claim went to the jury. The jury was unable to reach a verdict, and a mistrial was declared.
The plaintiff appealed to the court of appeals. The court of appeals held that, as part of the plaintiff’s informed consent claim, she was required to prove that a reasonable person knowing of the risk for spinal cord injury would have decided not to have the procedure performed. The court held that the discrepancy between the trial and deposition testimony went to the issue of credibility and that the trial testimony should not have been stricken. The Court of Appeals reversed the trial court’s grant of a directed verdict on the informed consent claim and remanded the case for a new trial.
What was the appropriate standard to be employed in this case where the patient alleges the physician did not provide informed consent?
The Tennessee Supreme Court held that informed consent cases are better resolved on an objective basis. The standard to be applied in informed consent cases is whether a reasonable person in the patient’s position would have consented to the procedure or treatment in question if adequately informed of all significant perils. The decision of the Court of Appeals was affirmed, and the case was remanded to the trial court for a new trial.
In Tennessee, the plaintiff in an informed consent medical malpractice case has the burden of proving: (1) what a reasonable medical practitioner in the same or similar community would have disclosed to the patient about the risk posed by the proposed procedure or treatment; and (2) that the defendant departed from the norm.
The issue with which the court was confronted was whether an objective, a subjective, or a hybrid subjective/objective test should be employed when assessing causation in informed consent cases. The majority of jurisdictions in Tennessee having addressed this issue follow an objective standard.
Under the objective analysis, the plaintiff’s testimony is only one factor when determining the issue of informed consent. The issue is not whether Ashe would herself have chosen a different course of treatment—the issue is whether a reasonable patient in Ashe’s position would have chosen a different course of treatment. The jury, therefore, should have been allowed to decide whether a reasonable person in Ashe’s position would have consented to the radiation therapy had the risk of paralysis been disclosed.
13.6 ASSESSING DECISION-MAKING CAPACITY
A patient is considered competent to make medical decisions regarding his or her care unless a court determines otherwise. The clinical assessment of decision-making capacity involves the patient’s ability to:
• Understand the risks, benefits, and alternatives of a proposed test or procedure
• Evaluate the information provided by the physician
• Express his or her treatment preferences
• Voluntarily make decisions regarding his or her treatment plan without undue influence by family, friends, or medical personnel
13.7 ADMISSION CONSENT FORMS
Admission consent forms signed at the time of admission are designed to record the patient’s consent to routine services, general diagnostic procedures, and the everyday routine touchings of the patient. Concerns for their use arise from the potential of unwarranted reliance on them for specific and potentially high-risk procedures or treatments.
13.8 CONSENT FOR SPECIFIC PROCEDURES
There are a variety of consent forms designed to more specifically describe the risks, benefits, and alternatives of particular invasive and noninvasive procedures. Such forms include consent for anesthesia, cardiac catheterization, surgery, radiation therapy, blood and blood by-products, chemotherapy, CT and magnetic resonance imaging (MRI) scans, endoscopy, and colonoscopy.
13.9 LIMITED POWER OF ATTORNEY
A limited power of attorney authorizes, for example, school officials, teachers, and camp counselors to act on a parents’ or legal guardian’s behalf when seeking emergency care for an injured student or camper. Such consent for treatment provides limited protection in the care of a particular child. Temporary consent indicates a parent or guardian’s intent to have a school official, teacher, or counselor to seek emergency treatment when necessary for the child for whom consent is provided.
13.10 WHO MAY CONSENT
Consent of the patient ordinarily is required prior to treatment. However, when the patient is either physically unable or legally incompetent to consent and no emergency exists, consent must be obtained from a person who is empowered to consent on the patient’s behalf. The person who authorizes treatment of another must have sufficient information to make an intelligent judgment on behalf of the patient.
A competent adult patient’s wishes concerning his or her person may not be disregarded. The court in In re Melideo held that every human being of adult years has a right to determine what shall be done with his or her own body and cannot be subjected to medical treatment without his or her consent. When there is no compelling state interest that justifies overriding an adult patient’s decision, that decision should be respected.
In Fosmire v. Nicoleau, the New York Supreme Court, Suffolk County, issued an order authorizing blood transfusions for a patient who had refused them. The plaintiff applied for an order vacating the court’s order. The appeals court held that the patient’s constitutional rights of due process were violated when the trial court issued an order authorizing blood transfusions in the absence of notice or opportunity for the patient or her representatives to be heard. The right of a competent patient to refuse medical treatment, even if premised on fervently held religious beliefs, is not unqualified and may be overridden by compelling state interests. However, a state’s interest in preserving a patient’s life in and of itself may not, under certain circumstances, be sufficient to overcome the patient’s express desire to exercise her religious belief and forgo a blood transfusion. The appellate division held, in part, that the state’s interest would be satisfied if the other parent survived.
The New York Court of Appeals, New York’s highest court, went further by stating that the citizens of the state have long had the right to make their own medical care choices without regard to their medical condition or status as parents. The court of appeals held that a competent adult has both a common law and statutory right under public health law to refuse lifesaving treatment. Citing the state’s authority to compel vaccination to protect the public from the spread of disease, to order treatment for persons who are incapable of making medical decisions, and to prohibit medical procedures that pose a substantial risk to the patient alone, the court of appeals did note that the right to choose is not absolute. However, if there is no compelling state interest to justify overriding a patient’s refusal to consent to a medical procedure because of religious beliefs, states are reluctant to override such a decision.
A guardian is an individual who, by law, is vested with the power and charged with the duty of taking care of a patient by protecting the patient’s rights and managing the patient’s estate. Guardianship is often necessary in those instances in which a patient is incapable of managing or administering his or her private affairs because of physical and/or mental disabilities or because he or she is under the age of majority.
Temporary guardianship can be granted by the courts if it is determined that such is necessary for the well-being of the patient. The court in In re Estate of Dorone granted temporary guardianship. In this case, the physician and administrator petitioned the court on two occasions for authority to administer blood. A 22-year-old male patient brought to the hospital center by helicopter after an automobile accident was diagnosed as suffering from an acute subdural hematoma with a brain contusion. It was determined that the patient would die unless he underwent a cranial operation. The operation required the administration of blood; however, the parents would not consent to the administration because of their religious beliefs. After a hearing by telephone, the court of common pleas appointed the hospital’s administrator as temporary guardian, authorizing him to consent to the performance of blood transfusions during emergency surgery. A more formal hearing did not take place because of the emergency situation that existed. Surgery was required a second time to remove a blood clot, and the court once again granted the administrator authority to authorize administration of blood. The superior court affirmed the orders, and the parents appealed.
The Pennsylvania Supreme Court held that the judge’s failure to obtain direct testimony from the patient’s parents and others concerning the patient’s religious beliefs were not in error when death was likely to result from withholding blood. The judge’s decisions granting guardianship and the authority to consent to the administration of blood were considered absolutely necessary in the light of the facts of this case. Nothing less than a fully conscious decision by the patient himself would have been sufficient to override the evidence of medical necessity in this case.
Parents generally have the right to authorize medical care for minor children, generally under the age of 18 years. Consent laws for minors often vary from state to state and should be referenced as necessary. Children who are emancipated have a right to make their own medical care decisions. While parents may have a right to refuse medical care in certain instances, such refusal is reportable by the caregiver to the state if such refusal can result in harm to the child.
When a medical or surgical procedure is to be performed on a minor, the question arises as to whether the minor’s consent alone is sufficient and, if not, from whom consent should be obtained. The courts have held, as a general proposition, that the consent of a minor to medical or surgical treatment is ineffective and that the physician must secure the consent of the minor’s parent or someone standing in loco parentis; otherwise, he or she will risk liability. Although parental consent should be obtained before treating a minor, treatment should not be delayed to the detriment of the child. Several courts have held the consent of a minor to be sufficient authorization for treatment in certain situations. In any specific case, a court’s determination that the consent of a minor is effective and that parental consent is unnecessary will depend on such factors as the minor’s age, maturity, mental status, and emancipation and the procedure involved, as well as public policy considerations.
Parental consent is not necessary when the minor is married or otherwise emancipated. Most states have enacted statutes making it valid for married and emancipated minors to provide effective consent. In Carter v. Cangello, the California Court of Appeals held that a 17-year-old girl who was living away from home, in the home of a woman who gave her free room and board in exchange for household chores, and who made her own financial decisions legally could consent to medical procedures performed on her. The court made this decision knowing that the girl’s parents provided part of her income by paying for her private schooling and certain medical care. The physician was privileged under statute to act on the minor’s consent to surgery, and such privilege insulated him from liability to the parents for treating their daughter without their consent.
Many states have recognized by legislation that treatment for conditions such as pregnancy, venereal disease, and drug dependency does not require parental consent. State legislatures have reasoned that a minor is not likely to seek medical assistance when parental consent is demanded, and that insisting on parental consent for the treatment of these conditions would increase the likelihood that a minor would delay or go without treatment to avoid explanation to the parents.
The Right to Choose
Abraham Cherrix was 16 years old when he was diagnosed in August 2005 with Hodgkin’s disease. He was treated with chemotherapy. In February of 2006, he learned that chemotherapy had not cured his disease. Doctors recommended a higher dosage of chemotherapy combined with radiation and culminating in stem cell therapy. The treatment program offered Abraham less than a 50% chance of survival. Abraham and his family chose to pursue alternative treatment in Mexico. Cherrix’s oncologist reported the family’s decision to the Accomack County Department of Social Services (ACDSS). Cherrix’s parents were accused of medical neglect by ACDSS. A judge granted the ACDSS temporary joint custody with the Cherrixes. The parents faced charges in the Juvenile and Domestic Court for parental neglect. The family obtained a stay from the Circuit Court.
The Accomack Virginia Circuit Court Judge cleared Abraham’s parents of all charges of medical neglect and allowed Abraham to pursue alternative treatment under a doctor of the family’s choice. A board-certified oncologist who is experienced in alternative cancer treatment will monitor Abraham. The family will provide the court updates on Abraham’s care every 3 months until he is cured or turns 18. The questions to be asked in this case include: Whose body is it anyway? Did the state go too far? The judge must have thought so.
The judge agreed to allow me to see an oncologist of my choice! My alternative treatments WILL continue. He also ruled that my parents were not guilty of medical neglect, and social services no longer has any jurisdiction over my case! Free, happy, and ready to live, that’s me!
13.11 INCOMPETENT PATIENTS
When there is doubt as to a patient’s capacity to consent, the consent of the legal guardian or next of kin should be obtained. If there are no relatives to consult, application should be made for a court order that would authorize a proposed procedure. It may be the duty of the court to assume responsibility of guardianship for a patient who is non compos mentis. The most frequently cited conditions indicative of incompetence are mental illness, mental retardation, senility, physical incapacity, and chronic alcohol or drug abuse.
A person who is mentally incompetent cannot legally consent to medical or surgical treatment. Therefore, consent of the patient’s legal guardian must be obtained. When no legal guardian is available, a court that handles such matters must be petitioned to permit treatment. Subject to applicable statutory provisions, when a physician doubts a patient’s capacity to consent, even though the patient has not been judged legally incompetent, the consent of the nearest relative should be obtained. If a patient is conscious and mentally capable of giving consent for treatment, the consent of a relative without the consent of the competent patient would not protect the physician from liability.
Citation: Greynolds v. Kurman, 632 N.E.2d 946 (Ohio Ct. App. 1993)
On July 29, 1987, Mr. Greynolds suffered from a transient ischemic attack (TIA), a sudden loss of neurologic function caused by vascular impairment to the brain. As a result of the TIA, Greynolds had garbled speech and expressive and perceptive aphasia (a medical term used to describe the loss of the power of expression by speech, writing, or signs, or of comprehending spoken or written language). Greynolds was taken to an emergency department, where Dr. Litman met him. At Dr. Litman’s request, Dr. Rafecas, a cardiologist, examined Greynolds. Dr. Rafecas determined that because of Greynold’s past medical history, which included previous TIAs, he was at a high risk for a stroke and sought to pinpoint the exact source of vascular insufficiency to the brain.
On August 3, 1987, after receiving the results of noninvasive tests, Dr. Rafecas ordered a cerebral angiogram. Dr. Kurman performed the angiogram. During the procedure, Greynolds suffered a stroke that left him severely disabled.
Greynolds and his wife filed a medical malpractice action against Dr. Rafecas and Dr. Kurman, asserting that Dr. Rafecas negligently recommended the procedure and that Dr. Kurman performed the procedure without obtaining the informed consent of the patient. Dr. Kurman argued that the trial court erred by refusing to enter judgment for him consistent with the answer to jury question number 3 (Id. at 949):
Question No. 1: Do you find there was a failure to obtain informed consent?
Question No. 2: If you answered Interrogatory No. 1 yes, then state specifically in what manner Dr. Kurman’s care fell below the recognized standards of the medical community.
Answer: Mr. Greynolds was not in our estimation capable of comprehending the consent form. Therefore, Dr. Kurman should have obtained consent from the next-of-kin, specifically, Mrs. Greynolds.
Question No. 3: If you answered yes to interrogatory No. 1 and you found that Mr. Greynolds did not consent to the procedure, do you find that a reasonable person would have consented to the procedure?
Kurman moved the trial court to grant him a judgment notwithstanding the verdict because the jury’s answer to interrogatory question number 3 was not consistent with the jury’s verdict. The trial court overruled Kurman’s motion and entered judgment for the plaintiffs, and Kurman appealed.
Was there sufficient evidence to support a judgment for the plaintiffs?
The court of appeals held that the evidence was sufficient to support a judgment in favor of the patient and his wife.
The jury needed to determine that the risks involved in the cerebral angiogram were not disclosed to Greynolds, that the risks involved in the procedure materialized and caused his stroke, and that a reasonable person in the position of Greynolds would have decided against having the angiogram had the risks associated with the procedure been disclosed to him. The jury concluded that Greynolds did not consent to the angiogram because he “was not … capable of comprehending the consent form,” and further noted that Kurman should have sought consent from the next of kin, specifically, the spouse. Given the evidence of Greynolds’s condition when he signed the consent forms, his past medical history, and the fact that he was at an increased risk to suffer complications during an angiogram, the court found that there was sufficient evidence to support a finding of lack of informed consent.
1. What would constitute informed consent?
2. Who should describe the risks associated with a procedure to the patient?
13.12 RIGHT TO REFUSE TREATMENT
… the individual’s right to make decisions vitally affecting his private life according to his own conscience … is difficult to overstate … because it is, without exaggeration, the very bedrock on which this country was founded.
—Wons v. Public Health Trust
Adult patients who are conscious and mentally competent have the right to refuse medical care to the extent permitted by law, even when the best medical opinion deems it essential to life. If a patient rejects treatment, the hospital should take all reasonable steps to inform the patient of the risks of refusing treatment. Every person has the legal right to refuse to permit a touching of his or her body. Failure to respect this right can result in a legal action for assault and battery. Coercion through threat, duress, or intimidation must be avoided.
A patient’s right to make decisions regarding his own health care is addressed in the Patient Self-Determination Act of 1990. The Act provides that each person has a right under state law (whether statutory or as recognized by the courts of the state) to make decisions concerning his or her medical care, including the right to accept or refuse medical or surgical treatment.
A competent patient’s refusal to consent to a medical or surgical procedure must be adhered to, whether the refusal is grounded on lack of confidence in the physician, fear of the procedure, doubt as to the value of a particular procedure, or mere whim. The U.S. Supreme Court stated that the “notion of bodily integrity has been embodied in the requirement that informed consent is generally required for medical treatment” and the “logical corollary of the doctrine of informed consent is that the patient generally possesses the right not to consent, that is, to refuse treatment.” The common law doctrine of informed consent is viewed as generally encompassing the right of a competent individual to refuse medical treatment.
The question of liability for performing a medical or surgical procedure without consent is separate and distinct from any question of negligence or malpractice in performing a procedure. Liability may be imposed for a nonconsensual touching of a patient, even if the procedure improved the patient’s health.
The courts perform a balancing test to determine whether to override a competent adult’s decision to refuse medical treatment. The courts balance state interests, such as preservation of life, protection of third parties, prevention of suicide, and the integrity of the medical profession, against a patient’s rights of bodily integrity and religious freedom. The most frequently used state right to intervene in a patient’s decision-making process is for the protection of third parties. The state of Illinois, in In re Fetus Brown, asserted that its interest in the well-being of a viable fetus outweighed the patient’s rights to refuse medical treatment. The state argued that a balancing test should be used to weigh state interests against patient rights. The appellate court held that it could not impose a legal obligation upon a pregnant woman to consent to an invasive medical procedure for the benefit of her viable fetus.
A patient’s refusal to consent to treatment, for any reason, religious or otherwise, should be noted in the medical record, and a release form should be executed (Figure 13-1). The completed release provides documented evidence of a patient’s refusal to consent to a recommended treatment. A release will help protect the organization and physicians from liability should a suit arise as a result of a failure to treat. The best possible care must be rendered to the patient at all times within the limits imposed by the patient’s refusal.
Should a patient refuse to sign the release, documentation of the refusal should be placed on the form, and the form should be included as part of the patient’s permanent medical record. Advice of legal counsel should be sought in those cases where refusal of treatment poses a serious threat to a patient’s health. With the advice of legal counsel, the organization should formulate a policy regarding treatment when consent has been refused. An administrative procedure should be developed to facilitate application for a court order when one is necessary and there is sufficient time to obtain one.
As part of their religious beliefs, Jehovah’s Witnesses generally have refused the administration of blood, even in emergency situations. Case law over the past several decades has developed to a point where any person, regardless of religious beliefs, has the right to refuse medical treatment.
The plaintiff, Bonita Perkins, in Perkins v. Lavin, was a Jehovah’s Witness. She gave birth at the defendant-hospital on September 26, 1991, and was discharged 2 or 3 days later. After going home, she began hemorrhaging and returned to the hospital. She specifically informed the defendant’s employees that she was not to be provided any blood or blood derivatives and completed and signed a form to that effect:
I request that no blood or blood derivatives be administered to (plaintiff) during this hospitalization, notwithstanding that such treatment may be deemed necessary in the opinion of the attending physician or his assistants to preserve life or promote recovery. I release the attending physician, his assistants, the hospital and its personnel from any responsibility whatever for any untoward results due to my refusal to permit the use of blood or its derivatives.
As a result of the plaintiff’s condition, it became necessary to perform an emergency D&C on her. She continued to bleed, and her condition deteriorated dramatically. Her blood count dropped, necessitating administration of blood products as a lifesaving measure. Her husband, who was not a Jehovah’s Witness, consented to a blood transfusion, which was administered. The plaintiff recovered and filed an action against the defendant for assault and battery and intentional infliction of emotional distress. The plaintiff’s claim as to assault and battery was sustained. The claim as to the intentional infliction of emotional distress was overruled.
The plaintiff specifically informed the defendant that she would consider a blood transfusion an offensive contact. The plaintiff submitted sufficient evidence to the trial court to establish that there was, at least, a genuine issue as to whether the defendant intentionally invaded her right to be free from offensive contact. Because of the plaintiff’s recognition that the defendant acted to save her life, a jury may find that she is entitled to only nominal damages.
13.13 EXCULPATORY AGREEMENTS
An exculpatory agreement is an agreement that relieves one from liability when he or she has acted in good faith. Exculpatory agreements in the medical setting are generally considered invalid.
In Cudnik v. William Beaumont Hospital, Mr. Cudnik underwent radiation therapy in March and April of 1985 after undergoing surgery for prostate cancer. Before receiving therapy, he signed a consent document that provided in part:
Further, my physician has fully explained to me the possibilities of reactions and the possible side effects of the treatment. I understand that there is no guarantee given to me as to the results of radiation therapy. Understanding all of the foregoing, I hereby release the physicians and staff of the Department of Radiation Oncology and William Beaumont Hospital from all suits, claims, liability, or demands of every kind and character which I or my heirs, executors, administrators [sic] or assigns hereafter can, shall, or may have arising out of my participation in the radiation therapy treatment regimen.
In early 1989, Cudnik returned to the hospital complaining of back discomfort, whereupon he was diagnosed as suffering from a postradiation ulcer burn at the site where he previously received radiation treatment. An action was brought against the hospital claiming that the negligent administration of radiation therapy contributed to Cudnik’s death. The defendant moved for summary judgment, and the Oakland Circuit Court granted the hospital’s motion after concluding that the exculpatory agreement between the parties precluded the plaintiff’s claims.
The plaintiff appealed, claiming that the hospital should be held vicariously liable for the medical malpractice of its employees or agents. As a general proposition, the parties to a contract may enter into an exculpatory agreement provided that it does not violate the law or contravene public policy. The question in this case is whether the plaintiff’s claim of medical malpractice is precluded by the exculpatory agreement between the two parties.
Exhibit 13-1 Refusal of care and treatment.
The court of appeals held that the exculpatory agreement executed by the patient prior to receiving radiation therapy was invalid and unenforceable to absolve a medical care provider from liability for medical malpractice. The agreement in this case is clearly against public policy. Further, the majority of jurisdictions have held that exculpatory agreements involving patient care are unenforceable.
Some exculpatory agreements in the medical setting are considered valid. For example, experimental procedures may require a different standard because, by their very nature, they require a deviation from generally accepted medical practices. In a case involving the patient’s last hope of survival, the New York Supreme Court held that “the parties may covenant to exempt the physician from liability for those injuries which are found to be the consequences of the nonnegligent, proper performance of the procedure.” The Cudnik case does not appear to involve an experimental procedure.
13.14 PROVING LACK OF CONSENT
The burden of establishing proof on a complaint of lack of informed consent is on the plaintiff. The plaintiff must establish that:
1. a reasonably prudent person in the patient’s position would not have undergone the treatment if fully informed, and
2. the lack of informed consent is the proximate cause of the injury or condition for which recovery is sought.
In a lawsuit, testimony would be necessary to establish the extent of the patient’s actual knowledge and understanding of the treatment rendered. It is possible for a patient, after treatment, to claim a lack of advance knowledge about the nature of a physician’s treatment, and it is possible that a jury will believe the patient and impose liability on the physician and/or the organization.
13.15 INFORMED CONSENT CLAIMS AND DEFENSES
Defenses available to defendants who have been sued based on failure to provide their patients with sufficient information to make an informed decision include the following:
1. Risks not disclosed are commonly known and do not warrant disclosure.
2. Patient assured the medical practitioner that he or she would undergo the treatment or procedure regardless of the risk involved, or the patient assured the medical practitioner that he or she did not want to be informed of the matters to which he or she would be entitled to be informed.
3. Consent was not reasonably possible by or on behalf of the patient.
4. The practitioner, after considering all of the attendant facts and circumstances, used reasonable discretion as to the manner and extent as to which alternatives or risks should be disclosed to the patient because the practitioner reasonably believed that the manner and extent of such disclosure could reasonably be expected to adversely and substantially affect the patient’s condition.
A patient’s condition during surgery may be recognized as different from that which had been expected and explained, requiring a different procedure than the one to which the patient initially consented. The surgeon may proceed to treat the new condition; however, the patient must have been aware of the possibility of extending the procedure.
The patient in Winfrey v. Citizens & Southern National Bank brought a suit against the deceased surgeon’s estate, alleging that during exploratory surgery, the surgeon performed a complete hysterectomy without the patient’s consent. The superior court granted summary judgment for the surgeon’s estate, and the patient appealed. The court of appeals held that even though the patient may not have read the consent document, when no legally sufficient excuse appeared, she was bound by the terms of the consent document that she voluntarily executed. The plain wording of the binding consent authorized the surgeon to perform additional or different operations or procedures that he might consider necessary or advisable in the course of the operation. Relevant sections of the consent signed by the patient included the following:
1. I authorize the performance on (patient’s name) of the following operation/laparoscopy, possible laparotomy…
2. I consent to the performance of operations and procedures in addition to or different from those now contemplated, which the above named doctor or his associates or assistants may consider necessary or advisable in the course of the operation. …
3. I acknowledge that the nature and purpose of the operation, possible alternative methods of treatment, the risks involved, and the possibility of complications have been fully explained to me.
1. Patient consent is an agreement by the patient to allow something proposed by another to be performed on his or her body.
2. Consent can be expressed verbally or in writing. It can be implied by statute or granted by the courts in cases where emergency care is needed to save the life of the patient.
3. Oral consent, although binding, is often difficult to corroborate, whereas written consent provides visible proof of a patient’s wishes.
4. Implied consent is generally presumed when immediate action is required to prevent death or permanent impairment of a patient’s health. In such cases, documentation justifying the need to treat before obtaining consent should be maintained.
5. Statutory consent provides that when a patient is clinically unable to give consent to a lifesaving emergency treatment, the law implies consent on the presumption that a reasonable person would consent to lifesaving medical intervention.
6. Judicial consent may be necessary in those instances where there is concern as to the absence or legality of consent. 7. Informed consent is a legal concept that provides that a patient has a right to know the potential risks, benefits, and alternatives of a proposed procedure.
8. Validity of consent
• Subjective standard: informed consent is determined by patient testimony.
• Objective standard resolves the issue of informed consent in terms of what a reasonably prudent person in the patient’s position would have decided if suitably informed of the risks, benefits, and alternatives of the procedure.
9. Liability for performing a medical or surgical procedure without consent is distinct from a question of negligence or malpractice in performing the procedure.
• A physician can be found liable for imposing nonconsensual treatment, even if that treatment improved the patient’s health.
10. Consent of a minor:
• Not generally valid to proceed with medical or surgical treatment.
• Not generally required if the minor is married or otherwise emancipated.
11. Consent for incompetent patients, assuming there is no designated family member or surrogate decision maker, can be obtained through application to a court for an order designating a decision maker to make the patient’s healthcare decisions.
12. Regardless of religious beliefs, patients have the right to refuse medical treatment.
• If a patient refuses treatment:
• the refusal should be noted in the patient’s medical record, and
• a release form should be executed that protects the provider from liability should the patient’s refusal to accept care result in injury.
13. An exculpatory agreement is an agreement that relieves one from liability when he or she has acted in good faith. However, these are generally considered invalid in the medical setting.
14. Defenses to claims that informed consent was lacking include:
• Risk not disclosed is commonly known and does not warrant disclosure.
• Patient stated he would undergo the procedure regardless of the risk involved
• Consent was not reasonably possible by or on behalf of the patient.
• The practitioner, after considering all of the attendant facts and circumstances, used reasonable discretion as to the manner and extent as to which alternatives or risks should be disclosed.