The basic requirements of informed consent were established in the early 1970s. Physicians must tell patients what is wrong with them, alternative methods of treatment, and the risks and benefits of the alternative treatments, including the risks and benefits of no treatment. All "material" risks and benefits must be disclosed. The test for determining what is material differs depending on the jurisdiction. Some states use the "professional standard," where the test is what a reasonable physician would disclose. A growing number of states use the "reasonable patient" standard, where the test is what a reasonable patient would want to know in order to make an informed choice. A small number of states use a third test -- what the "actual patient" would want to know.

Since these basic requirements were established, a number of questions have arisen concerning whether physicians must inform patients about what might be called "extrinsic" risks. These are risks that are not inherent in the methods of treatment themselves. These risks could arise from characteristics of the hospital where the treatment is to be provided, such as an acute nursing shortage, from the fact that the expiration date has expired on a sample of medicine that the physician proposes to give the patient, and so on. This Cyberounds^® focuses on another source of extrinsic risk: the specific characteristics of the physician.

Infectious Physicians

The first time this issue came up was in the 1980s at the beginning of the AIDS epidemic.

Q. Must a surgeon who is HIV-positive disclose this fact to her patients? What do you think?

A. There is no clear rule, but the consensus seems to be that as long as an HIV-positive physician refrains from performing invasive procedures, there is no need to disclose the physician's HIV status to patients. The rationale is that, in the case of non-invasive activities, the risk of infecting patients is so low as to be immaterial, while the damage that disclosure would cause to the physician's ability to practice would be catastrophic.

What if the HIV-positive physician wants to engage in invasive procedures? There appear to be three different approaches. One seems to say that the physician may proceed so long as she discloses her HIV-positive status to patients. This is the approach adopted by a Maryland court in Faya v. Almaraz, 620 A.2d 327 (Ct. App. 1993), a case in which the court allowed patients to sue a surgeon for their fear of contracting AIDS.

Another approach is to forbid HIV-positive physicians from engaging in invasive procedures, with or without their patients' consent. This seems to be the approach taken by the AMA Council on Ethical and Judicial Affairs, which states: "A physician who knows that he or she is seropositive should not engage in any activity that creates a significant risk of transmission of the disease to others."(1) The CDC takes a third approach, which is to require seropositive physicians to consult with expert medical authorities as well as to disclose their seropositive status to patients.(4)

Impaired Physicians

Another situation in which disclosure of extrinsic risks comes up is in the case of impaired physicians. It is clear that a physician should not treat patients while under the influence of drugs or alcohol.

Q. But should a physician be required to inform patients that she is an alcoholic or that she uses illegal drugs in her spare time?

A. The case law is split. One case, Hidding v. Williams, 578 So.2d 1192 (La. 1991), held that an alcoholic physician had a duty to disclose his condition to patients. The plaintiffs' contention was not that the doctor was inebriated while performing the surgery in question -- a laminectomy that resulted in the patient becoming incontinent -- but that the doctor failed to disclose that he was a chronic alcoholic, which increased the risk that he might be impaired when he treated patients.

On the other hand, the Supreme Court of Georgia in 2000 held that since the state statute requiring informed consent did not specifically mention disclosure of drug use, a physician who used cocaine outside of work and while not on call was not required to disclose this to his patients. [Albany Urology Clinic, P.C., v. Cleveland, 528 SE 2d 777 (Ga. 2000).] And in Kaskie v. Wright, 589 A.2d 213 (Super. Ct. Pa. 1991), a Pennsylvania court ruled that the parents of a child who died after surgery following an automobile accident could not sue a surgeon on the basis that the surgeon failed to disclose the fact that he was an alcoholic and unlicensed. The Pennsylvania court's explanation for its ruling is instructive:

[W]e refuse to expand the informed consent doctrine to include matters not specifically germane to surgical or operative treatment. To do so where, the absent information consists of facts personal to the treating physician, extends the doctrine into realms well beyond its original boundaries. Nor are limitations easily definable. Are patients to be informed of every fact which might conceivably affect performance in the surgical suite?

We'll return to the views of the Pennsylvania courts later.

Financial Conflicts of Interest

In the wake of the rise of managed care, a vigorous debate has ensued regarding whether physicians must disclose financial conflicts of interest to their patients. In Moore v. Regents of University of California, 793 P.2d 479 (Ca. 1990), the California Supreme Court held that physicians must disclose their intent to commercialize a patient's spleen cells, since this might affect their judgment about what was best for the patient.

Similarly, in Shea v. Eisensten, 208 F.3d 712 (8th Cir. 2000), the U.S. Court of Appeals for the Eighth Circuit allowed the plaintiff to go forward with a claim that physicians negligently failed to inform her husband of managed care financial incentives to limit access to care. If he had been informed, his wife alleged, her husband would have obtained a second opinion about the need for a cardiology referral, possibly preventing him from dying of heart failure.

But in Neade v. Portes, 739 N.E.2d 496 (Ill. 2000), the Illinois Supreme Court blocked the estate of a patient who died from a heart attack from suing physicians for failing to disclose financial incentive arrangements with an HMO that allegedly caused them to deny the patient an angiogram. The court felt that disclosure of financial incentives was the duty of the HMO, not the physicians.

Ghost Treatment

What about ghost treatment? A "ghost" is a person who provides treatment instead of the physician who obtain the patient's informed consent. It can be other physicians such as residents and fellows, medical students, non-physicians such as physician assistants and nurse-practitioners, and even detail-persons from drug and device manufacturers. Ghosts are a particular concern in surgery, where the patient may not be conscious or in a position to recognize and object that someone else is performing the procedure.

Q. Must a surgeon disclose to the patient that someone other than the surgeon will be performing the procedure?

A. The general sentiment appears to be that patients must be informed about who will be treating them, and that substituting one provider for another is a breach of the duty to obtain patients' informed consent. Some courts go even further, deeming this to be more than mere malpractice -- a type of negligence -- but a battery, which has several important implications: First, the patient need not prove that anything went wrong with the procedure, or that she suffered any adverse effects; she can recover damages merely for being "touched" without her consent. Second, the patient need not prove "causation" -- namely, that had she been told who was really going to treat her, she would not have proceeded with the operation. Finally, unlike being sued for malpractice or failing to obtain the patient's informed consent, being sued for a battery may make the defendants liable for punitive damages.

But the definition of what constitutes ghost treatment may not be clear, at least to patients. The AMA Council on Ethical and Judicial Affairs states that "[a] surgeon who allows a substitute to operate on his or her patient without the patient's knowledge and consent is deceitful. The patient is entitled to choose his or her own physicians and should be permitted to acquiesce to or refuse the substitution."(2) But the ethics opinion goes on to state:

Under the normal and customary arrangement with patients, and with reference to the usual form of consent to operation, the operating surgeon is obligated to perform the operation but may be assisted by residents or other surgeons. With the consent of the patient, it is not unethical for the operating surgeon to delegate the performance of certain aspects of the operation to the assistant provided this is done under the surgeon's participatory supervision, i.e., the surgeon must scrub. If a resident or other physician is to perform the operation under non-participatory supervision, it is necessary to make a full disclosure of this fact to the patient, and this should be evidenced by an appropriate statement contained in the consent. Under these circumstances, it is the resident or other physician who becomes the operating surgeon.

This language appears to distinguish three situations: being assisted by residents or other surgeons, which only requires "the usual form of consent to operation;" delegating the performance of certain aspects of the operation to an assistant, which requires "the consent of the patient" and scrubbing in by the supervising surgeon; and having the assistant perform the operation under "non-participatory supervision," which requires "full disclosure" to the patient.

Clearly, having someone else perform the entire procedure is a violation of the duty to obtain informed consent. The question is how well patients understand the "the usual form of consent to operation" as meaning that someone other than the surgeon may be "assisting," and whether patients can tell the difference between when others are simply "assisting" and when they are "performing certain aspects of the operation," since one way to read the AMA opinion is that only the latter requires some sort of specific patient consent. And, of course, there is always the question of how often these obligations are in fact carried out.

Skill and Experience

In recent years, a new set of issues has arisen with regard to disclosure of extrinsic risks. Must a physician disclose her skill and experience? For example, if the physician has never performed a certain procedure before, but is recommending it to the patient, must the patient be informed of the physician's lack of experience?

Q. What do you think?

A. The courts, it turns out, are split. In Johnson v. Kokemoor, 545 N.W.2d 495 (Wis. 1996), a patient suffering from headaches was referred to a neurologist, who operated on her for an enlarging aneurysm at the bifurcation of the basilar artery. The surgery left the patient an incomplete quadriplegic, unable to walk or control her bowel or bladder functioning and with partial impairment of her vision, speech and upper body coordination. Prior to the surgery, the patient had questioned the surgeon about his experience, and was told that he had performed the surgery in question "dozens" and "lots" of times. In fact, although he had performed 30 aneurysm surgeries during his residency and six since then, he had operated on basilar bifurcation aneurysms only twice, and had never operated on a large basilar bifurcated aneurysm such as the plaintiff's.

The plaintiff contended that the surgeon should have advised her of his limited experience and referred her to a more experienced surgeon, who could have been found at the Mayo Clinic, only 90 miles away. A jury decided in favor of the plaintiff, but an appellate court reversed, stating that a physician had no duty to divulge the extent of his experience to patients. The Supreme Court of Wisconsin reinstated the verdict, holding that "[a] reasonable person in the plaintiff's position would have considered such information material in making an intelligent and informed decision about the surgery."

In 2002, the Supreme Court of New Jersey reached a similar result in Howard v. University of Medicine and Dentistry of New Jersey, 800 A.2d 73 (N.J. 2002). A defendant, Robert Heary, who was Professor of Neurosurgery and director of the UMDNJ's Spine Center, performed surgery to correct the plaintiff's cervical myopathy secondary to cervical stenosis and a significantly large C3-C4 disc herniation. The patient was rendered a quadriplegic.

According to the plaintiff, Dr. Heary had said that he was board-certified in neurosurgery and that he had performed 60 corpectomies during the 11 years he had practiced neurosurgery. In fact, Heary was only board-eligible, and he had performed only approximately 24 corpectomies. In addition to suing the physician for malpractice, the plaintiff's sought to sue him for fraud and deceit. The Supreme Court of New Jersey declined to permit the plaintiff to pursue the fraud-and-deceit claim, but held that he could proceed on the basis that the physician had failed to obtain his informed consent to the procedure. The court's reasoning includes an illuminating discussion of the difference between intrinsic and extrinsic risks:

We recognize that a misrepresentation about a physician's experience is not a perfect fit with the familiar construct of a claim based on lack of informed consent. The difficulty arises because physician experience is not information that directly relates to the procedure itself or one of the other areas of required medical disclosure concerning the procedure, its substantial risks, and alternatives that must be disclosed to avoid a claim based on lack of informed consent. But the possibility of materiality is present. If defendant's true level of experience had the capacity to enhance substantially the risk of paralysis from undergoing a corpectomy, a jury could find that a reasonably prudent patient would not have consented to that procedure had the misrepresentation been revealed. That presumes that plaintiff can prove that the actual level of experience possessed by defendant had a direct and demonstrable relationship to the harm of paralysis, a substantial risk of the procedure that was disclosed to plaintiff. Put differently, plaintiff must prove that the additional undisclosed risk posed by defendant's true level of qualifications and experience increased plaintiff's risk of paralysis from the corpectomy procedure.

Note the court's requirement that the plaintiff convince the fact-finder not only that a reasonable patient would have wanted accurate information about the physician's level of experience, but that the physician's lack of experience increased the risk of complications from the treatment. This should be fairly easy for the plaintiff to prove, since it is well-accepted that the more experienced the surgeon, the better the outcome.(9)

But other cases have rejected this type of claim. In Ditto v. McCurdy, 947 P.2d 952 (HI 1997), the Supreme Court of Hawaii ruled that a physician does not have an affirmative duty to disclose his or her qualifications to a patient prior to providing treatment. The plaintiff had been disfigured as a result of breast-augmentation surgery. She claimed, among other things, that the physician, who was certified as a cosmetic surgeon by the American Board of Cosmetic Surgeons, which is not recognized by the American Society of Medical Specialties, had a duty to inform her that he was not board-certified by the ASMS-recognized American Board of Plastic and Reconstructive Surgeons.

In the Johnson case, the patient had actually questioned the doctor about his experience, while in Howard, the surgeon had actively misrepresented his relative lack of experience. In Ditto, on the other hand, the physician simply failed to disclose the specific nature of his board certification. Perhaps, then, the decisions in these cases can be reconciled by saying that, while as in Ditto, a physician has no affirmative duty to accurately describe his qualifications and experience, the physician must not misrepresent his abilities and must make a truthful disclosure when asked by the patient.

Another Pennsylvania case, Duttry v. Patterson, 771 A.2d 1255 (Pa. 2001), however, throws cold water on this reasoning. In Duttry, a throat cancer patient had questioned the surgeon about how often he had performed the type of surgery he had recommended. The surgeon allegedly told her that he did the procedure approximately once a month. In fact, he had only done it nine times in the past five years. After the patient suffered complications following a rupture at the site of the surgery, she sued, claiming that the physician's misrepresentation deprived her of the ability to give her informed consent. The Supreme Court of Pennsylvania sided with the defendant, holding that "the evidence of a physician's personal characteristics and experience is irrelevant to an informed consent claim." Importantly, the court added that this conclusion does not change even if the patient specifically asks about the physician's experience.

Virtually all commentators have excoriated the Pennsylvania court for its decision. Surely, physicians may not lie to patients when asked directly about their qualifications and experience. Indeed, it is contrary to the spirit of the informed consent doctrine to expect physicians to disclose their relative lack of experience only when asked.

Only in Pennsylvania?

How can the Duttry case be explained?

First, it is a decision from Pennsylvania, and we have already seen that Pennsylvania judges take an extremely narrow view of the requirements of informed consent, refusing, in the Kaskie case, to require a physician to disclose that he is an alcoholic. It turns out that there is something peculiar about the Pennsylvania law of informed consent. Remember the previous discussion about battery in connection with ghost surgery? Recall that if a physician's misbehavior is considered a battery rather than just negligence, the plaintiff does not have to prove that the treatment itself was faulty in any way or that, given the correct information, the plaintiff would have refused to proceed with the treatment. Originally, failing to obtain a patient's consent was regarded as a battery, but over the years, the courts have rejected this view and treated lack of informed consent as a negligent act. But not in Pennsylvania. In Pennsylvania, lack of informed consent is still a battery. So the courts in Pennsylvania do not want to make it easy for patients to be able to sue physicians for lack of informed consent.

Another explanation comes from a recent article in the Stanford Law Review, in which Mark Hall suggests, somewhat paradoxically, that the reluctance of courts to require physicians to disclose extrinsic risks may stem from a desire to promote patient trust.(5)

Which position do you think is correct? Should physicians be required to disclose their experience and qualifications? Only when asked?