For the Newsletter for the Eastern Cardiothoracic Surgical Society Standard and Ethics Committee
As mentioned in a previous newsletter, the American Law Institute (ALI) has published a recommendation that medical malpractice law should change the requirements of negligence from reliance on customary care i.e., care that a reasonable physician would do if faced with the same or similar circumstances, to a requirement to use guidelines based on evidence-based practice. A physician not following guidelines would then have the burden of proof shifted to him to show why the guidelines were not followed.
The ALI, which is composed of lawyers, judges, and other legal scholars, based their recommendation on the premise that patients would be better served if their care was based on the guidelines which were formulated by medical experts based on best evidence. I have commented on this recommended change in a previous newsletter.
Not surprisingly, the ALI has also taken a stance on the law of informed consent. Traditionally, the states have taken two approaches in determining what information the health care providers would need to present to the patient, or the patient’s surrogate, so that an informed decision can be made. In both approaches, the patient needs to be given “material” information. Unfortunately, the ALI did not clarify what the “material” information should be in both approaches.
In both approaches, the patient must be allowed to ask questions and the provider should answer the questions to the best of his ability.
Many patients have limited knowledge of medical issues so it is a challenge for the provider to know how much information should be conveyed so that adequate informed consent can be given. The provider-oriented duty to disclose was dependent on the community standard to disclose what a reasonable physician within the community would disclose under the same or similar circumstances.
In “provider-centered jurisdictions, information is ‘material’ if it would be shared by ‘competent…medical providers of the same type in similar circumstances’”1 The provider-centered approach has been criticized for being too paternalistic and at odds with the concept of patient autonomy being paramount in medical ethics.
Recognizing that the community standard tended to protect physicians by limiting standard disclosures which may not have been in the patients’ best interest, the D.C. Circuit Court of Appeals changed the duty to disclose standard in the case of Canterbury v. Spence2.
In Canterbury, a patient was undergoing a laminectomy for back pain. He fell out of bed and became paralyzed. Spence sued because he had not been told of this possible complication.
The surgeon had not told Spence about this possible complication because it was rare (1%) and he believed that Spence would not have consented for this indicated procedure if this possibility was raised.
The D.C. Circuit decided that the following would be “material” information needed for the patient (or designated surrogate) for an informed consent to occur. The provider would need to disclose “(1) the condition being treated; (2) the nature and character of the proposed treatment or surgical procedure; (3) anticipated results; (4) recognized possible alternative forms of treatment; and (5) recognized serious possible risks, complications and anticipated benefits…”3 (emphasis added)
In the “patient-centered jurisdictions, information is ‘material’ if a reasonable person, in what the provider knows or should know to be the patient’s position, would likely attach significance to the information in deciding whether to consent to the treatment.”4 Tennessee uses this patient-centered approach.
The patient-centered approach has been adopted by most states and by the American Medical Association. Unfortunately, these required disclosures are vague and undefined. The ALI had an opportunity to clarify these “material” issues, but they chose not to.
For some reason, the ALI has not chosen to push for the patient-centered approach for informed consent despite the legal push for this doctrine. In the Reporters’ Notes, ALI suggests that current medical professionals are being trained in medical ethics and are now aware of the importance of patient autonomy and professional practice is now following the patient-centered approach even where the state law allows for physician-centered practice.
I think the ALI is not being realistic if it believes that the provider-centric and patient-centric approaches will equally embrace the goal of patient autonomy and self-determination as to informed consent.
No matter which approach is used for the patient consent process, the ALI still leaves unresolved consequences of providers’ failure to comply with the patient’s direction. If the physician does a procedure for which he does not have consent, he would be liable for negligence in New York; but the same case would be a battery in Georgia. The ALI could have clarified this area of legal confusion, but they did not.
Also, it is still unclear how the law should handle the situation where the physician does not provide the medical care that the patient does consent to. This is the murky area of futile care. Most states will not compel physicians to provide care they deem to be futile, but they may still face a malpractice suit alleging failure to provide competent care. Again, the ALI does not weigh in on this issue, so providers need to familiarize themselves with the law in their state. The lack of uniformity of the laws makes providing care even more difficult than it already is.
What about the situation where the patient (or the surrogate) makes it clear that the patient should not be told any bad news about his medical condition? This is not a rare occurrence in some religions or cultures. The ALI could have clarified this issue, but they did
not. For now, if the patient (or surrogate) opts out of the consent process, then a quick call to a judge may need to be done. The judge may even give the decision-making power back to the physician; a complete turn back to the medical paternalism of the past. Very ironic.
What if a patient asks the surgeon about his level of expertise dealing with the recommended surgical procedure? In most states, surgeons are not required to reveal specific information about themselves, but in Johnson v. Kokemoor, the court held that the physician may have to disclose this information if a reasonable person would need this information to give informed consent.5 In Johnson, Johnson ended up a quadriplegic after Kokemoor, a neurosurgeon, clipped an aneurysm of the posterior basilar artery. Johnson argued that she should have been referred to a more experienced surgeon.
The ALI did nothing to clarify as to the “materiality” of this type of question.
I predict that the ALI will eventually succumb to the push to make the informed consent process using the patient-centered approach to avoid any chance of reverting back to medical paternalism.
As to futile care, be sure you know the laws of your state to avoid being sued for denial of care under the “loss of chance” doctrine.
Darryl Weiman, M.D., J.D.
1 Restatement (Third) of Torts: Medical Malpractice section 12 (c)(1) (Am.L. Inst., Tentative Draft No. 1, 2023). 2 Canterbury v. Spence, 464 F2d 772 (DC Cir 1972). 3 Id. 4 Restatement (Third) of Torts: Medical Malpractice section 12(c)(1) (Am. L. Inst., Tentative Draft No. 1, 2023). 5 Johnson v. Kokemoor, 545 NW2d 495 (Wis 1996).