Medicolegal Issues in the Care of Patients with Neurologic Illness

Maria R. Schimer

Lois Margaret Nora

key points

Excellent communication skills, including the ability to listen effectively, are among the most important risk management skills that the physician can employ.
Treating physicians have a legal duty to their patients to possess a reasonable degree of skill and knowledge, to use care and diligence in exercising this skill and knowledge, to employ approved methods in general use, and to use their best judgment.
Informed consent is a process that has essential legal requirements including a legally and clinically competent patient, who is given adequate and understandable information about the proposed medical intervention by the treating physician and who voluntarily agrees to the intervention.
Competent patients, or their surrogate decision makers, may withdraw their consent for a medical intervention.
When determining death using neurologic criteria, the clinical evaluation should be done by experienced examiners who adhere to the recognized practice
parameters and follow institutional requirements to establish the diagnosis.
Documenting advice and directives that are given to a patient with neurologic disease who wishes to drive is an important risk management strategy. All states have Department of Motor Vehicle Web sites that can provide information helpful in determining driving regulations for patients who are impaired for any reason.

In recent years, legal aspects of medical practice have become increasingly visible and important, particularly in the care of patients with neurologic disease. Although some physicians are intimidated by medicolegal issues, knowledge of legal aspects of medical practice can give the clinician a greater sense of mastery and may reduce the defensive practice of medicine and thus promote better patient care.

Three important types of law affect medical practice: case law, statutory law, and administrative law. Case law (also known as the common law) is developed by both the state and the federal courts (the judicial system) through the resolution of various criminal and civil matters. The decisions of these courts form a body of law that is binding within a given jurisdiction because of a legal doctrine known as stare decisis, or the doctrine of precedent, which requires courts to follow earlier court decisions when the same legal question arises again. A court’s jurisdiction is the geographic or subject matter area over which that court has decision-making authority. Within any jurisdiction, courts are divided into trial courts and appellate courts.

Physicians are often most concerned with the law developed by the judicial system because this is where the majority of law in the area of medical malpractice arises. The law which is developed in this area has a substantial impact on malpractice insurance premiums for physicians. Medical malpractice is generally a civil action heard in a court that is part of a state court system. However, if the alleged malpractice occurred in a federal facility (e.g., a Veterans Administration hospital), the matter is heard in a federal court because of the provisions of the Federal Tort Claims Act.

Most medical malpractice actions allege that the physician (Defendant) was negligent in the care of the patient (Plaintiff).

▪ SPECIAL CLINICAL POINT: To win a lawsuit alleging professional negligence, the Plaintiff must demonstrate by a “preponderance of the evidence” (greater or stronger evidence) (a) that the physician had a duty of care to the patient, (b) that the physician breached that duty, (c) that the breach proximately caused injury to the Plaintiff, and (d) that the injury resulted in damage to the Plaintiff.

Duty arises at the beginning of a patient-physician relationship and continues until the relationship is appropriately concluded through proper written notification to the patient by the physician or patient withdrawal from the relationship. Generally, a patient-physician relationship arises when a physician first sees a patient in a patient care setting and agrees to be the patient’s physician. The concept of duty in this context has several components including the duties to (a) possess a reasonable degree of skill and knowledge, (b) use reasonable care and diligence in exercising this skill and knowledge, (c) employ approved methods in general use, and (d) use his or her best judgment.

▪ SPECIAL CLINICAL POINT: The injury alleged must have been caused by some particular thing that the Defendant either did or
failed to do which a physician of ordinary skill, care, and diligence would or would not have done under like or similar circumstances. It must then be proven that the injury was directly and proximately caused by the Defendant’s action or inaction; attorneys often call this the “but for” test. Expert medical testimony is provided by another physician who, through experience and education, has developed sufficient skill and knowledge in a particular area of medicine to be able to form and give an opinion that will assist the judge or jury in deciding the case.

The second body of law affecting a physician’s medical practice is statutory law. Statutory law is the body of law developed by local, state, or federal legislative bodies; this body of law applies to persons within the jurisdictional bounds of those legislative bodies. Examples of such statutory laws include the federal and state statutes concerning medical malpractice, abortion, advance directives (living wills and health care powers of attorney), and termination of treatment. Laws must be consistent with the United States Constitution, which is the most fundamental and organic source of law, and with the individual state’s constitution. When a statute is unclear or when it is in conflict with the Constitution (federal or state) or another statute, the judicial system is employed to clarify or interpret the statute or to resolve conflicts.

▪ SPECIAL CLINICAL POINT: Administrative law is a body of law with three distinct components: the enabling legislation that creates the governmental agency and gives it its powers; the rules and regulations that are promulgated by the agency in accordance with the power granted to it; and the body of opinions, reports, and orders that the agency issues.

An example of an agency that regulates some aspects of clinical practice is the U.S. Food and Drug Administration (FDA). Among other areas of authority, the FDA regulates pharmaceuticals and medical devices. Another agency, the Office for Human Research Protections (OHRP), has regulatory authority over much of the research involving patients.

The Health Insurance Portability and Accountability Act (HIPAA) is an example of a federal law that is administered by the Office of Civil Rights at the Department of Health and Human Services through multiple administrative regulations. These regulations dramatically affect the patient care environment and expand upon the longstanding responsibilities of physicians to honor patient confidentiality. For example, the HIPAA privacy rules regulate the gathering of information from patients, electronic sharing and storage of information in the medical record, and communication of such information with patients’ family members and others. HIPAA rules impose substantial penalties for noncompliance by physicians and organizations.

The remainder of this chapter addresses three specific areas at the intersection between medical and legal matters and the care of patients with neurologic illness. These areas are (a) informed consent, a legal principle that affirms patient self-determination; (b) the use of neurologic criteria to declare death; and (c) the licensing of drivers with neurologic disorders, with a focus on seizure disorders.

INFORMED CONSENT

Informed consent is a fundamental legal concept based on medical ethics. The purpose of obtaining informed consent is to promote the autonomy of the patient in medical decision making. Informed consent involves two distinct legal rights of the patient: the right to obtain information and the right to make a decision. The informed consent process, which is best thought of as shared decision making, requires that the treating physician disclose sufficient information to enable the patient to evaluate a procedure before consenting to it.

▪ SPECIAL CLINICAL POINT: Informed consent is predicated on several important assumptions. These assumptions are that the patient (a) is competent, (b) is free from duress,
(c) has received the disclosure of necessary information from the treating physician in a manner that renders the information understandable, and (d) has voluntarily given permission or made a choice.

To give informed consent, a patient must be competent. The President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research wrote that competence involves the possession of a set of values and goals, the ability to communicate and understand information, and the ability to reason and deliberate about one’s choices. Although this is an excellent standard by which to measure competence, the clinical practitioner often deals with situations in which the patient’s abilities fluctuate over time and vary depending on the functional domain. It is helpful to understand the construct that the patient must be both legally and clinically competent to provide informed consent for a medical intervention.

Adults are presumed to be legally competent unless they have been declared legally incompetent by a court of law. When a person has been declared incompetent by the court, the court names a guardian who stands in the place of the incompetent person (ward) for all purposes set forth in the guardianship documents. Although many well-meaning family members confuse the two, the practitioner must be careful to distinguish between documents signifying that a person is under guardianship and those signifying that a person has given another person the power to act for him or her in the event of incompetence, that is, a health care power of attorney. A physician’s failure to secure consent before providing treatment may result in charges of battery (criminal, civil, or both) and malpractice.

▪ SPECIAL CLINICAL POINT: The general rule is that a competent adult may consent to, refuse to consent to, or withdraw consent for treatment in any form.

Generally, minors are not considered legally competent. Consent for the treatment of minors must, in most cases, be sought from their guardians, usually their parents. However, there are exceptions. A minor who has been legally emancipated is considered legally competent to make medical decisions. In addition, minors may be legally competent for certain interventions but not for others. For example, in some states adolescents are considered legally competent to make reproductive health decisions, even though they lack legal competence to make other medical care decisions.

▪ SPECIAL CLINICAL POINT: Legal competence, by itself, is not enough. A person must also be clinically competent.

Clinical competence implies that the patient can understand information, formulate a decision, and communicate that decision. Assistive devices (e.g., hearing aids, glasses, or communication devices) can be helpful in maintaining a patient’s clinical competence. Clinical competence is a medical decision. In some situations, a person may be legally competent but not clinically competent. Dementia, encephalopathy, and other conditions may render the patient incapable of providing informed consent for a variable period.

In situations where it is impossible to secure consent from the patient because the patient is incompetent, the physician must consult a surrogate decision maker for the patient. This person is often the patient’s next of kin. The decision maker may also be a person appointed earlier by the patient through a written advance directive, or a court-appointed guardian.

▪ SPECIAL CLINICAL POINT: Two distinct legal standards have been established for surrogate decision makers. These standards are the substituted judgment standard and the best interest standard.

The substituted judgment standard requires the surrogate decision maker to review the patient’s known beliefs, previous actions, statements, and any available documentation, to determine what decision the patient would have made. Put
simply, the surrogate decision maker must “put himself or herself in the place of the patient.” The best interest standard requires the surrogate decision maker to look at all of the facts and circumstances surrounding the case and to attempt to identify the action that, in the minds of most persons in the jurisdiction, would be in the best interest of the incompetent patient.

The second requirement for informed consent is that adequate information be provided to the patient in an understandable fashion. Information provided to the patient should include the nature and purpose of the proposed intervention, its risks and anticipated benefits, alternatives to the proposed interventions, prognosis without the intervention, and prognosis with alternative interventions. The patient should be told of the right to refuse and to withdraw consent at any time.

▪ SPECIAL CLINICAL POINT: Although other health care personnel may be involved in obtaining consent, the physician remains responsible for ensuring the provision of adequate information and for the other aspects of the informed consent process.

The adequacy of information provided to a patient can be an issue in malpractice suits. Two legal standards of information disclosure are recognized: the professional standard and the material risk standard. The professional standard requires the physician to give the patient information that other physicians of the same specialty, in the same community, would give to patients considering the same intervention. At trial, expert testimony is necessary to determine the nature and extent of this information. This is the more traditional of the two standards and is currently preferred in most jurisdictions.

The material risk standard requires the physician to provide any information that a reasonable person in the patient’s position would want disclosed or would use in making a consent decision. Advocates of this standard identify its emphasis on the patient’s need for information. Opponents point to its retrospective application as a serious disadvantage. The most appropriate approach is probably a hybrid of the two standards.

▪ SPECIAL CLINICAL POINT: Physicians should communicate those risks that occur often enough or that are so severe, even if they occur infrequently, that a patient would usually wish to know of them.

For example, patients should be advised of the possibility of hirsutism and gingival hyperplasia with phenytoin use, and they should be given information about spinal headaches before undergoing lumbar puncture. In addition, if a physician is aware of a particular characteristic of a patient that would make a potential adverse effect more important to that patient, this adverse effect should be communicated, even if the physician would not have discussed it with other patients. For example, potential teratogenic effects of medications should be discussed with female patients who may become pregnant.

The third requirement of informed consent is that the patient must give consent voluntarily. Coercion and duress invalidate consent. A physician should provide patients with advice and guidance regarding proposed therapies, but this must be done in a noncoercive manner. No explicit or implicit threat of loss of medical or nursing care should be linked to a decision.

The consent discussion should be documented in the patient record. A patient-signed consent document is not required for valid consent, but it provides at least some evidence of decision making by the patient. Although prepared consent forms can be helpful, the value of these documents should not be overestimated. Courts and juries are often suspicious of complicated consent documents that appear to be written more to protect the physician than to inform the patient.

Care must be taken that interventions remain within the scope of the consent given by the patient. Consent should be secured for a given procedure, for other procedures that are
within the scope of that procedure, and for procedures that can or should be reasonably expected. Consent usually is given to a particular person and to those working with that person. The physician should not overextend the consent to procedures that are not logically associated with the consent or to personnel not reasonably anticipated by the patient.

▪ SPECIAL CLINICAL POINT: In emergency situations, the guidelines for informed consent do not strictly follow the standard informed consent principles.

When a patient is unconscious or incompetent (by reason of mental impairment) and has sustained injuries that are likely to result in the imminent loss of life, and no surrogate decision maker is available, the health care professionals caring for the person are required to act in accordance with reasonable medical standards to save the patient’s life.

It is also important to recognize that a competent patient may “waive” the right to informed consent by “letting the doctor decide” what course of action to take in a given situation. For example, the patient may say, “I am not a physician. I trust you; that is why I came here. Do what you think is best.” Some would argue that this is not a waiver at all, but rather a conscious decision on the part of the patient to let another make a critical judgment. Although courts recognize the right of a patient to waive informed consent, physicians should make sure that waiver decisions are carefully documented, and they should have the patient put the waiver in writing.

Therapeutic privilege is another exception to informed consent. This exception is used when the physician determines that an informed consent discussion will prove so detrimental to the patient’s health that it should not be undertaken. For example, some physicians have used this exception to justify not disclosing the risk of tardive dyskinesia when neuroleptic medications are prescribed to certain patients who, they fear, will refuse a potentially beneficial medication because of a severe, but unlikely, side effect.

Physicians must be extremely cautious in their use of therapeutic privilege. Courts may not be sympathetic to physicians’ defending their use of therapeutic privilege when confronted by an uninformed patient who has suffered severe adverse effects. If a physician believes that the use of therapeutic privilege is absolutely necessary, involving the patient’s family in the decision may be beneficial, but this involvement must not violate the patient’s privacy. Complete disclosure to the patient at the earliest opportunity is also advisable. The physician should maintain contemporaneous and clear documentation of the reasons for the decision.

▪ SPECIAL CLINICAL POINT: The right of a competent patient to give informed consent carries with it an obvious recognition of the patient’s right of informed refusal. Patients have a legal right to refuse interventions, even if the refusal will result in the patient’s death.

Physicians must inform patients of potential problems related to refusing a potential intervention, and this action should also be documented. Education and persuasion of the patient are two important tools available to the physician when a patient refuses consent. When a physician is confronted by a patient refusal that may result in serious adverse consequences for the patient and the physician is uncertain whether the refusal is the result of a patient’s inability to perceive the nature and extent of his or her clinical predicament (e.g., where the patient is in a state of early to mid-stage dementia), a psychological or psychiatric consult may be helpful.

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