Defending the informed consent case: analyzing the materiality of the risk, causation, and expert testimony requirements.

• Author: Cobb, William G.

A PATIENT'S physician should provide him or her with relevant and material information regarding the physician's proposed treatment. Disclosing information relating to patient treatment enables the patient to knowingly consent to--or to reject the treatment that the health care provider is proposing. As Justice Cardozo stated in the often cited case of Schloendorff v. Society of New York Hospital, "every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent, commits an assault, for which he is liable in damages." (1)

Based upon the disclosure (or nondisclosure) of any risks attendant to such treatment, the issue ultimately becomes whether a reasonably prudent person in the patient's position (or, in certain jurisdictions, whether the patient him or herself) would have consented to the treatment or procedure in light of those risks. The failure to obtain consent for treatment was traditionally considered a battery (2) (or as Justice Cardozo characterized it, an assault). However, most jurisdictions now simply view the failure to address material risks of treatment with the patient as a form of malpractice described as "negligent nondisclosure." (3)

The material information which should be discussed with the patient is that information which would be considered by the "reasonably prudent patient" as significant when evaluating whether to proceed with the treatment. Information or risks that the reasonably prudent patient knows and commonly appreciates are not material. There is no duty to disclose risks where the procedure is simple, the danger is remote, and it is commonly understood to be remote. (4) Conversely, some jurisdictions have held that where a procedure is inherently associated with a known risk of death or serious injury, the health care provider must disclose those risks and discuss the potential complications with the patient, regardless of how remote the risk may be. (5)

Therefore, the first step in defending an informed consent case is ascertaining whether the non-disclosed risk was material. Expert testimony may be required to determine whether the risk was material, depending upon the jurisdiction where the case is filed. Almost every jurisdiction has embraced the concept that the patient should be informed of material risks. Jurisdictions part company on the issue of whether informed consent trials require expert testimony with respect to whether a health care provider under similar circumstances would have discussed those material risks with the patient.

Most of the cases interpreting the informed consent issue have arisen in the context of medical malpractice lawsuits. However, it appears that those jurisdictions which have considered the issue have applied the medical malpractice dogma to other health care professionals, such as chiropractors. (6) Defense practitioners should also be aware that the forum where the cause of action arose may have enacted specific state statutes governing the disclosure of information to a patient. (7)

There are two schools of thought for determining whether a material risk should have been discussed with the patient. One approach allows jurors without the assistance (or necessity) of expert testimony to place themselves "in the position of a patient and decide whether, under the circumstances, the patient should have been told of the risk." (8) This approach is referred to as the "material risk" or "patient oriented" standard, and it is based upon the concept that a patient should be adequately informed about risks prior to choosing to undergo a medical procedure. (9)

The other viewpoint on informed consent has been labeled the "professional standard" or the "physician oriented" standard. This approach requires expert testimony from a qualified health care provider who, based upon the standard in the appropriate scientific community, decides whether the information is material and should be disclosed to the patient. (10)

Defense practitioners must ascertain whether the forum jurisdiction embraces the "material risk" standard or the "professional physician oriented" standard, the latter of which requires expert testimony with respect to whether the health care provider should have disclosed any risks to the patient. In either category of jurisdictions, however, except in a few rare instances (such as where a surgeon neglected to remove a surgical instrument and failed to disclose this action with the patient (11)), expert testimony will be required to discuss the materiality, if any, of the risk. Risks which are "immaterial" as a matter of law will not need to be addressed with the patient.

The last step of the analysis pertains to causation. Defense practitioners must determine whether the jurisdiction applies a subjective or objective test with respect to whether the patient would not have consented to the procedure if he or she had have been informed of the risk. The second component of the causation test requires proof that the non-consensual procedure actually caused plaintiff's injuries.

I. The Two Approaches of Informed Consent

1. The Material Risk (Patient-Oriented) Standard

   The patient-based standard of informed consent stresses the patient's right to self-determination and the fiduciary relationship between a doctor and a patient. This standard balances the patient's need for material information with a physician's discretion. It requires a physician to disclose material information to the patient even if the patient does not ask questions. (12)

   The material risk standard was discussed in greater detail in Woolley v. Henderson, a 1980 Maine Supreme Court decision. (13) The Court analyzed the rationale behind the material risk standard in the following way:

   [A]n increasing number of courts hold that because a physician's obligation to disclose therapeutic risks and alternatives arises from the patient's right of physical self-determination, the disclosure duty should be measured by the patient's need for information rather than by the standards of the medical profession. These courts reason that physicians have a legal obligation adequately to disclose risk and option information that is material to the patient's decision to undergo treatment and that expert testimony as to medical standards is not required to establish this duty. Under this "material-risk" standard, although expert medical testimony may be necessary to establish the undisclosed risk as a known danger of the procedure, the jury can decide without the necessity of a medical expert whether a reasonable person in the patient's position would have considered the risk significant in making his decision. (14) Under this approach, the nature of the risk associated with the treatment is brought to the jury's attention, usually through expert testimony. Even those jurisdictions which have adopted the material risk standard also embrace the concept that if a risk itself is not material, it need not be addressed with the patient. (15) Although expert testimony will not be received in these jurisdictions as to whether the risks should have been discussed with the patient, expert testimony will nevertheless be required to evaluate the materiality (or severity or significance) of the risk.

   However, assuming the risk is material, or even assuming there is a dispute among experts as to the materiality of the risk, the jury without expert testimony will be allowed to determine whether the patient consented to the procedure with adequate knowledge. Without relying on what the standard may or may not be in the health care community, the jury is permitted in its own discretion to determine whether the health care provider should have disclosed such risks with the patient.

   The plaintiff then has the burden of going forward with evidence of nondisclosure. Once the plaintiff has established that the physician failed to address known material risks, then the physician typically bears the burden of submitting evidence to justify nondislosure or to show that a legally sufficient disclosure was made. (16)

   Assuming the jury finds the risk was material and the physician failed to adequately address the risk of treatment, the next step in the material risk jurisdiction (as well as in a "professional standard" jurisdiction) is to determine whether the reasonably prudent patient (or in some jurisdictions, the plaintiff) would or would not have consented to that treatment.

2. The Professional Disclosure (Physician-Oriented) Standard

   A small majority of jurisdictions has adopted the "professional disclosure" or "physician oriented" standard. Under this approach, as the Court of Appeals for South Carolina explained in Hook v. Rothstein, the physician "is required to disclose those risks which a reasonable medical practitioner of like training would disclose under the same or similar circumstances." (17) The Hook court went on to note that, "[i]n most cases, the questions of whether and to what extent a physician has a duty to disclose a particular risk are to be determined by expert testimony which establishes the physician's departure from that standard." (18)

   The rationale for this approach is that an informed consent case is no different from any other malpractice action wherein a departure from the accepted standard of care must be established by expert testimony. As the Supreme Court of Missouri stated in Aiken v. Clary:

   The basic philosophy in malpractice cases is that the doctor is negligent by reason of the fact that he has failed to adhere to a standard of reasonable medical care, and that consequently the service rendered was substandard and negligent. In our judgment, this is true whether the alleged malpractice consists of improper care and treatment (the usual malpractice case) or whether it is based, as here, on an alleged failure to inform the patient sufficiently to...