Lack of Informed Consent and Refusal

CHAPTER 14 Lack of Informed Consent and Refusal



Hugh F. Hill, M.D., J.D., F.A.C.E.P., F.C.L.M.




GOLDEN RULES



1. Patient autonomy outweighs your professional opinion and your good intentions.

2. The patient’s consent protects the provider.

3. For consent to serve as a defense, it must be “meaningful,” i.e., real.
(a) The patient has to know what he is consenting to.

(b) The patient has to have the intellectual capacity to consent.

4. A signed form can be a manifestation of, but not a substitute for, actual consent.

5. Treat refusal of recommended care like informed consent. Make it an “informed refusal.”

6. Obviously necessary care can be refused without it being “crazy”, but such refusal does raise the question.

7. In a nonemergency situation, get questions of who can consent for the patient clarified first.

8. People in another’s custody, be it police or family or nursing home, are not automatically unable to refuse treatment.

9. Where anyone has or might raise capacity questions, document your basis for your assessment.

10. Approach every single informing session, for consent or refusal, the same way you approach patients every day: with ultimate concern for their wellbeing, and respect for them as individuals.



CASE PRESENTATION


Imagine yourself, after a long and distinguished career, now serving as a hospital’s Clinical Administrator. Today, the real “suits” are off doing whatever and you are temporarily in charge. Suddenly, an agitated group bursts into your office.


“You’ve got to do something!,” demands a surgeon.


“Right now!,” explodes from several throats.


You quickly learn that a patient is on the operating table for a triple A repair, but the charge nurse refuses to let the case proceed because there is no signed consent form in the chart. The patient has been medicated, but is not yet asleep. Everyone in your office has an opinion. Your senior scrub nurse points out that the patient came for the surgery and climbed off the gurney onto the table. The surgeon believes the patient will sign now and, besides, the surgeon already has another form signed at his office. The anesthesiologist doesn’t want to agitate what he believes is a high-risk patient.


You check your own pulse, taking a moment to appreciate how nice your day had been—up until now.



ISSUES


Most of what we understand about informed consent we learned by exposure to routine practice in our training, and most of it is correct. Patients who voluntarily seek medical attention have agreed to accept the usual basics of history and physical and even a few common procedures, like vital sign measurements. Patients manifest further acceptance of simple slightly invasive procedures, like blood drawing, by holding out their arm, or rolling up their sleeve on request. So, in the case above, the scrub nurse’s comments about the hypothetical patient make some sense.


For surgery involving general anesthetics, we all expect that the patient will have to sign something permitting the procedure. A hospital’s rules may require it, or just by experience we know that this paperwork has to be completed before the operation. We speak of “consenting the patient” or of “getting the informed consent signed.” The charge nurse above is doing his job by insisting on the proper form. But that situation is unusual. Is a reflexive order to reschedule the surgery the best response?


The majority of health care interactions are straightforward. But marginal situations, questions about details of informed consent, and refusals of recommended care all require some understanding of the applicable law. In this chapter, we will reach that understanding by a quick simple review of background and principles.1 A few examples will demonstrate application of that understanding and we will try to unravel the knotty situation our imaginary Clinical Administrator confronts. Then, we will put it all together with survival strategies—the questions you want answered.



Background


Our law grew out of real controversies decided by courts. Judges followed the precedent of rules laid out in previous similar cases, and patterns of reasonable expectations appeared. In the dim past, categories may have appeared naturally, and lawyers began to ask courts to rule for their clients by citing these categories. In each category, criteria (and thus defenses) developed into requirements, including both theories and facts. Informed consent law’s precedents appear in the category of suits for “battery.”


The word is familiar to us in association with acts of violence: a “battery” of artillery, a “battering” ram, a “battered” woman. The English common law came to define “battery” as a harmful or offensive unpermitted touch. Even from our childhood, we recall the line drawn between words and touching. Through cases and decisions, judges made it clear that all injuries resulting from the touch were injuries for which the victim could sue.


This rule about the extent of liability for an unpermitted touching may be clearer with an example from a nonmedical context. A vulnerable plaintiff can recover for even surprising injuries from simple contact: a push or shove of an individual with a bleeding diathesis might cause major problems. Lawyers speak of the “thin-skulled plaintiff” and say the tortfeasor, the person causing the harm, “takes his victims as he finds them.” The injured party’s vulnerability is not a defense—the accused defendant has to try and show that the contact was in fact permitted, explicitly or implicitly (such as by participation in a sport). Thus, predictably, questions arose about what was “permitted.”


In the common law of battery, consent could be given in words, by behavior, or implied in the circumstances. The law of battery applied to medical treatment. (The common law early created an exception for emergencies.) In the medical context, lots of touching is expected, but without consent, liability for battery can follow. The early cases, and even into the first half of the last century, were not concerned with extent of information communicated, but rather whether or not there was any consent and often with procedures that went beyond what the patient had expected.


Remember that this law early developed in a pre-anesthetic era. Particularly in amputations, a surgeon’s speed was prized. A 19th-century description captures the essence: The surgeon and his assistants would approach the patient, the instruments concealed behind their backs. The patient would be asked one more time if he would have it (the limb) off. If he agreed, the assistants held the patient down and the surgeon proceeded, regardless of any objections the patient might subsequently raise. But what happened when the patient later claimed he had never consented, or had been duped, or the job was botched?


Patients could sue for compensation. If the procedure—the touching—had been consented to, the patient had to prove negligence, i.e., that the operator failed to meet the standard of care. But if the patient could assert that there was no consent, then the operator could be liable for all injuries, even if the procedure was flawless!


Thus, today, when a patient or family member goes to the lawyer’s office to discuss the possibility of a lawsuit against a health care professional or institution, consent can be pivotal. If the patient never consented, it is a very different case. In some states, the lawyer will not have to hire expert witnesses to prove negligence. Think about this in reverse, and you will never forget the importance of being able to prove that your patient consented. If the lawyer cannot find an expert to say there was negligence, he may be left with nothing except attempting to claim that there was no consent!


This brief history lesson should begin to reveal several points. Consent is not just another piece of aggravating paperwork, consent can serve as a critically important defense to a lawsuit, and consent can be manifested in various ways. You may have some hint of why legal battles focus on procedures, even though some of the drugs we prescribe entail hazards as well. And we also begin to beg some of the questions that often arise, such as “Did the patient really consent?” and “What was the extent of the consent, what did he consent to?”



“Informed” Consent


This term that we all now use did not appear in the law until 1957. We know there were earlier cases focused on the extent of the procedure permitted, but the content of the consent got little attention otherwise. Historically, plaintiffs could attack the validity of a consent based on fraud or misinformation. Now, in the last 50 years, lack of information can invalidate the patient’s consent.


The public’s growing perception of an ethical duty to warn of consequences of procedures was influenced by new research codes. Nazi medical experiment atrocities evoked the Nuremberg Code, which said that research subjects’ voluntary consent is valid only if they know what is to be done to them, its hazards, and the effects on their health.2


Following 1960, courts throughout the country addressed cases involving claims of a duty to warn and the idea that consent had to be informed. States differ in how they have incorporated the doctrine. Many have moved suits for lack of informed consent out of battery and into medical malpractice. A few states disallow suits for battery based on lack of informed consent; many keep the claims for complete lack of consent in battery and apply medical malpractice procedures to suits based on the adequacy of the information communicated.


Many state legislatures have passed statutes on informed consent. Those statutes articulate meanings developed through case law and precedent. Some statutes address the adequacy of the “informed” part of the definition.


Whether a creature of tradition or statute, the question is: How much information must be communicated and understood to make the patient’s consent informed? Our hypothetical aneurysm patient voluntarily got onto the operating table, but does the hospital know how much information and what information he had before he demonstrated his willingness to undergo the procedure?


We all have the general idea that patients have to know basically what is proposed, the expected outcome and the risks of the proposed procedure, what may happen if the procedure is not attempted, and what alternatives exist. For many procedures, we could make a long list for several of those elements. It makes sense to start with the most common ones, but then how far down the list should we go? In addition to not wanting to take unnecessary time discussing a list of maybes, we realize that it is possible to confuse a patient with TMI—too much information.


American law has two approaches to answering the “how much” question. Like many legal decision rules, reviewing courts apply a test.


What would a reasonable physician say? The first test that courts used was the “reasonable physician”: What would a reasonable physician tell a patient? This community standard is closer to a standard of care analysis for negligence, requiring expert testimony.


What would a reasonable patient want to know? Many states now apply the “reasonable patient” guidance: “What would a reasonable patient want to know before undergoing the procedure?” Predictably, this shift meant more litigation, and initially left providers guessing or overreacting. The reasonable patient standard can be further modified to make it more idiosyncratic. The standard jury instruction in an informed consent case in the District of Columbia reads: “That _______ was a risk which a reasonable patient, acting under the same or similar circumstances as the plaintiff, would likely think of as something he should know in making a decision as to the treatment he is to receive….”

Related posts:

  1. Professional Liability Insurance
  2. Medical Malpractice Stress Syndrome
  3. Miscellaneous Torts
  4. Neonatology and Pediatrics

Stay updated, free articles. Join our Telegram channel
Tags:
Mar 25, 2017 | Posted by in GENERAL & FAMILY MEDICINE | Comments Off on Lack of Informed Consent and Refusal

Full access? Get Clinical Tree
Get Clinical Tree app for offline access