SPECIAL REPORT

Medicolegal Aspects of Informed Consent in the ED

By Randall Best, MD, JD, Assistant Professor, Division of Emergency Medicine, Department of Surgery, Duke University School of Medicine, Durham, NC.

Anyone recently considering an elective medical procedure knows that physicians' efforts in obtaining proper informed consent have become increasingly elaborate. The use of detailed educational materials and videos are common. However, in the emergency department (ED) there has not been a similar trend. Usually, such elaborate efforts are not practical due to the urgency of the treatment or procedure under consideration. Even so, with the current emphasis on patient autonomy and satisfaction, it is likely that the informed consent process in the ED will receive increased scrutiny along with corresponding heightened medicolegal concerns.

A better understanding of the legal issues involved in obtaining informed consent can serve as a starting point to enable emergency physicians to consistently meet their medical, ethical, and legal obligations. Under American tort law, the failure to obtain informed consent in and of itself does not provide a proper cause of action. Rather, that failure may serve as a theory under which a recognized tort claim such as battery or negligence may be pursued.1 Battery is defined as an intentional and offensive touching of another without lawful justification.2 Medical malpractice, a doctor's failure to exercise the degree of care and skill that a physician of the same medical specialty would use under similar circumstances, is a type of negligence.3 The elements of a malpractice negligence action are as follows:

1. Duty;

2. Breach of that duty;

3. Harm to the patient; and

4. Causation that the breach of duty caused the harm.4

Thus, a medical malpractice claim for failure to obtain informed consent would allege that the physician defendant breached the duty to obtain informed consent and that breach constitutes a proximate cause of the harm suffered by the patient plaintiff.

Likely unknown by most physicians, the area of informed consent has an extensive legal history. The seminal case requiring a physician to obtain his patient's "informed consent" is Salgo v. Leland Stanford, Jr. University Board of Trustees, where the court held that a physician "violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment."5 Jurisdictions employ one of three separate approaches to determine whether a physician has properly provided informed consent.6 Historically, the majority employed the physician-based standard set forth in Fain v. Smith that the "doctor's duty to get the informed consent of the patient must be measured by a professional medical standard."7 A second, increasingly common approach is the "reasonable patient" or "objective standard" as held in the landmark case of Canterbury v. Spence that makes the reasonable patient the measure of the scope of disclosure by requiring a physician to disclose information a reasonable patient would desire.8 The final approach, termed the subjective standard, espoused in Scott v. Bradford, requires a doctor to disclose information that would be material to decision making for the particular patient in question thus preserving the individual patient's rights of self-determination.9 That approach has been adopted in only a few jurisdictions. Courts more commonly agree with the reasoning of Canterbury that the reasonable patient standard is fairer for physicians as it relieves the doctor from the need to anticipate any unusual peculiarities of a particular patient as well as avoiding placing the "physician in jeopardy of the patient's hindsight and bitterness" if a lawsuit develops.10

Increasingly, states have codified common law judicial decisions into statutory law. For example, North Carolina has combined the requirements of the physician based and reasonable patient standards under statutory law as follows:11

Informed consent to health care treatment or procedure.

(a) No recovery shall be allowed against any health care provider upon the grounds that the health care treatment was rendered without the informed consent of the patient or other person authorized to give consent for the patient where:

(1) The action of the health care provider in obtaining the consent of the patient or other person authorized to give consent for the patient was in accordance with the standards of practice among members of the same health care profession with similar training and experience situated in the same or similar communities; and

(2) A reasonable person, from the information provided by the health care provider under the circumstances, would have a general understanding of the procedures or treatments and of the usual and most frequent risks and hazards inherent in the proposed procedures or treatments which are recognized and followed by other health care providers engaged in the same field of practice in the same or similar communities; or

(3) A reasonable person, under all the surrounding circumstances, would have undergone such treatment or procedure had he been advised by the health care provider in accordance with the provisions of subdivisions (1) and (2) of this subsection.

In interpreting this statute, North Carolina courts have concluded that negligence actions based upon a health care provider's failure to obtain informed consent require testimony of a qualified expert to establish the requisite standard of care for providing informed consent.12

Clark v. Perry provides illustration of the proper application of this statute.13 Clark, a practicing Jehovah's Witness, developed complications of AIDS and was admitted to the hospital by his personal physician, Dr. Jacinto. Dr. Jacinto was aware of Clark's religious beliefs and his desire not to receive blood products. Clark's medical chart contained this information, as well. During the hospitalization, Dr. Jacinto consulted Dr. Perry, a pulmonologist, who subsequently performed a bronchoscopy. Upon being notified of a significant drop in hemoglobin after the procedure, Dr. Perry ordered a blood transfusion on Clark. Clark was not awake during the transfusion of the first unit. He and his wife later became aware that blood had been transfused when a nurse prepared to administer the second unit. Clark's wife later testified that they both became extremely upset and remained so until his death a short time later. Other witnesses offered conflicting testimony as to the degree that Clark and his wife suffered emotional distress.

Ms. Clark filed suit against Dr. Jacinto, Dr. Perry, and the hospital. Among the allegations in her complaints included a claim of negligence for failure to obtain informed consent for the blood transfusion. Subsequently, she dismissed Dr. Jacinto from the lawsuit and the case proceeded against the remaining defendants. At the close of plaintiff's evidence, the remaining defendants moved for a directed verdict. On the issue of whether the defendants were negligent in failing to obtain informed consent, the trial court granted the motion for a directed verdict in favor of the defendants citing the plaintiff's failure to meet her evidentiary burden to establish the applicable standard of care for obtaining informed consent. Clark appealed.

The appeals court upheld the decision of the trial court. The court agreed with the plaintiff that North Carolina law ordinarily places a duty for a health care provider to obtain informed consent for procedures and treatment rendered.14 In determining whether or not the duty to obtain informed consent has been met, the standard of care for that process must be established. Here, the plaintiff failed to produce any evidence of the standard of care. The court concluded: "In particular, plaintiff presented no expert testimony tending to show whether Dr. Perry's actions were 'in accordance with the standards of practice among members of the same health care profession with similar training and experience situated in the same or similar communities' [as required by] G.S § 90-21.13(a)(1). Therefore, as plaintiff did not meet her evidentiary burden with respect to the standard of care element of her negligence allegation against Dr. Perry based upon failure to obtain informed consent, we hold the trial court properly allowed the motion for directed verdict thereon."15

Emergency physicians rarely learn how to obtain proper informed consent in a formal fashion. Rather, that particular skill is honed through observation and practice with the result that the process can be quite haphazard and variable yielding a patient consent process that may in truth be both non-informative and non-consensual. Employing a standard, consistent approach with some understanding of the legal requirements can improve the process and provide peace of mind for the emergency physician that at least that aspect of patient care will not result in legal ramifications.

While the practice of medicine is to a large degree standard throughout the United States, the medico-legal aspects of health care frequently are not. Although legal issues governed by federal laws such as the Emergency Medical Treatment and Active Labor Act (EMTALA) and Health Insurance Portability and Accountability Act (HIPAA) do not vary from state to state, those that pertain to malpractice actions do vary because state law governs those claims. In particular, there is significant variation between states on which of the standards discussed above is employed to judge physician informed consent efforts. Therefore, it behooves emergency physicians to be aware of the informed consent laws in their state. That knowledge can provide the framework for a consistent, legally defensible informed consent process. Although what physicians truly want is immunity from a claim being filed at all, the best that can be hoped for is a robust and winning defense. A physician who can demonstrate an understanding of the legal requirements of proper informed consent and can articulate why those requirements were met is likely to prevail on the issue of whether or not the duty to obtain informed consent was met or breached.

For instance, in North Carolina, the successful physician defendant will be one who effectively testifies that the patient was given sufficient information that would enable a reasonable person to have a general understanding, including risks, of the procedure or treatment and that the information was given in accordance with the standards of practice among members of the same health care profession.

Even so, with the current emphasis on patient autonomy and satisfaction, it is likely that the informed consent process in the ED will receive increased scrutiny along with corresponding heightened medicolegal concerns.

References

1. Barry R. Furrow et al., Health Law 311-13 (2d ed. 2000).

2. Black's Law Dictionary 162 (8th ed. 2004).

3. Id. at 978.

4. Id. at 1061-62.

5. Salgo v. Leland Stanford Jr. Univ. Bd. of Trustees, 317 P.2d 170 (1957).

6. Furrow at 313-315.

7. Fain v. Smith, 479 So.2d 1150 (Ala. 1985).

8. Canterbury v. Smith, 464 F.2d 772 (D.C. Cir. 1972)

9. Scott v. Bradford, 606 P.2d 554 (Okla. 1980).

10. Canterbury, 464 F.2d at 790-91.

11. N.C. Gen. Stat. § 90-21.13(a) (2008).

12. Nelson v. Patrick, 58 N.C. App. 546 (1982).

13. Clark v. Perry, 114 N.C. App. 297 (1994).

14. McPherson v. Ellis, 305 N.C. 266 (1982).

15. Clark, 114 N.C. at 310.