BIOETHICS
October 1, 1999

Informed Consent

In the modern field of health law and bioethics, the doctrine of informed consent is about as classic a doctrine as we have. Essentially, it means that a physician must present the patient with alternatives, along with information about the pros and cons of the alternatives, and then proceed with the option that the patient selects. In theory, there is always an alternative: even where there is only one recognized treatment or approach, the patient can always choose to do nothing.

While simple in theory, informed consent raises a number of questions. What alternatives should the physician tell the patient about? When is a risk too remote or minor, or a benefit too trivial or speculative, to be worth mentioning?

The prevailing legal standard is that a physician must inform the patient of whatever a reasonable physician would inform the patient. This means that, in a dispute over whether the physician obtained the patient's informed consent, the parties will be required to bring in expert testimony, typically from other physicians, about what a reasonable physician ought to tell a patient under the circumstances.

Some states have adopted a different legal standard that a physician must provide whatever information a reasonable patient, or the actual patient in question, needs in order to make an informed decision. In these jurisdictions, the parties cannot introduce expert testimony on the adequacy of informed consent; instead, the matter is left up to the jury (or the judge, if the case is being tried without a jury) to decide, based on their own experiences and attitudes.

Generally speaking, the more information a physician provides patients about the alternatives and their pros and cons, the more difficult it will be for the patients to complain that the physician has not given them adequate information. But information is not without cost — in terms of time, and in terms of the risk of provoking patient anxiety and confusion.

Let's deal with some of the tricky questions that arise in connection with informed consent. In my answers, I'll give you references to cases, but bear in mind that the law may be different in your location. When in doubt, check with a local health care attorney.

Does the physician have to inform you of "alternative" (or, as they are sometimes called, "complementary") medical approaches, or just of "orthodox" or "mainstream" approaches?

The basic rule is that a physician is required to inform the patient only of "medically indicated" or "medically viable" options.

When is an alternative approach "medically indicated" or "viable"?

There is virtually no case law on the subject. (This may mean that there is little risk for the physician who fails to mention alternative approaches to patients. But this may mean instead that the growing interest in and, some might say, legitimizing of, non-mainstream medical approaches is too new a phenomenon for lawsuits to have been filed complaining of lack of informed consent because of the failure to mention non-mainstream approaches.) The only case is Del Valle Rivera v. United States, 630 F. Supp. 750 (D.P.R. 1986), in which the Veterans Administration was held not liable for failing to recommend "sclerotherapy" to a patient as an alternative to surgery for bleeding from esophageal varices. According to the court, sclerotherapy had been experimented with and largely abandoned years earlier, although it still was being tried in a few hospitals at the time.

One place that we could look for an answer to our question might be the other side of the coin, i.e., when is the use of a non-mainstream approach reasonable? In most jurisdictions, the answer is: when the non-mainstream approach is endorsed by a "respectable minority" of physicians. So we might turn this around to say that a physician should inform a patient of an alternative approach if a respectable minority of physicians would do so.

Another answer might be for the physician to inform the patient that the physician is going to provide information about mainstream approaches, but that some other physicians might recommend other, non-mainstream approaches, and that if the patient wishes, she can contact these other physicians.

As mentioned earlier, by and large, the more information that the physician provides to the patient, the less the risk that the patient will be able to sue the physician for lack of informed consent. But in the case of alternative approaches, the physician must be careful not to appear to recommend an approach that is so far from accepted medical practice that it would be malpractice to provide it to the patient. This leads to our next question.

Suppose the physician would like to recommend a non-mainstream approach to diagnosing or treating the patient's problem. If the physician obtains the patient's informed consent, does this protect the physician against being sued for malpractice for using the non-mainstream approach?

This presents a fundamental clash between the principles of patient autonomy and physician beneficence. On the one hand, we want to allow patients to make choices for themselves, even when they opt for unconventional therapies. On the other hand, we want to protect them from quackery.

One situation that may arise is when the physician gets the patient not only to give informed consent to proceed with a non-mainstream approach, but to agree not to sue the physician because the physician used that approach.

Courts generally frown upon so-called "releases of liability," and refuse to allow them to bar a suit for malpractice. The courts reason that patients typically are not in a position to refuse to sign releases of this sort, and therefore that it would be unfair to make such a release binding on the patient. (See, for example, Tunkl v. Regents of the University of California, 383 P.2d 441 [Cal. 1963] ). Yet at the same time, it is generally accepted that patients who give their informed consent to participate in a legitimate medical experiment cannot then sue the physicians merely for using experimental techniques. (See, for example, Colton v. New York Hospital, 98 Misc. 2d 957, 414 N.Y.S.2d 866 [N.Y. Sup. Ct. 1979] ).

In one of the few cases to address the validity of an informed consent form signed by a patient purporting to release a physician from liability for using a non- mainstream approach, a federal court held that the release might be valid, and that it was up to the jury to decide whether the patent was adequately informed about the risks and benefits of the approach and had freely made the choice to proceed. "[W]e see no reason," said the court in this case, Schneider v. Revici, 817 F.2d 987, 995 (2d Cir. 1987), "why a patient should not be allowed to make an informed decision to go outside currently approved medical methods in search of an unconventional treatment." In this case, the patient had sought treatment for breast cancer from a physician who purported to treat the disease with selenium and dietary restrictions.

It should be noted that, even when a patient agrees not to sue a physician for employing a non-conventional technique, the physician still may be liable for negligently performing the technique. In the Schneider case, for example, even if the doctor was not liable for using selenium and dietary restrictions to treat breast cancer, he could be liable if he prescribed a toxic dose of selenium.

Does the physician have to tell the patient about an option that the patient's insurance will not pay for? Probably. The patient may wish to use her own funds to purchase the non-covered services. Or, the patient may wish to challenge the insurer's refusal to pay for them, such as by arguing that the insurer is misreading the terms of the insurance contract, or is discriminating against the patient on grounds of disability. Failing to inform the patient of non-covered but potentially beneficial interventions denies the patient these opportunities.

"Gag" provisions in physician contracts with managed care organizations may attempt to forbid physicians from discussing with patients the need for non-covered services. These provisions are unlawful in a growing number of states, and in any event, are almost certainly not enforceable against the physician.

You may be familiar with Oregon's Medicaid program, which ranks all medical services in order of importance and only covers those that the legislature feels it can afford. By law, physicians in Oregon cannot be sued for malpractice for failing to provide a Medicaid patient with a service that the legislature will not pay for, but they can be sued if they fail to inform Medicaid patients of the benefits from non-covered services. (Oregon Revised Statutes §414.725(5) [1995]).

Does the physician have to inform the patient that more accomplished physicians are available to perform a recommended procedure?

Quite possibly. In Johnson v. Kokemoor, 545 N.W.2d 495 (Wis. 1996), the court held that a surgeon should have informed his patient that he was not experienced in performing an operation to clip a basilar bifurcated aneurysm, so that the patient could have sought the surgery from a more experienced surgeon.

The duty to obtain the patient's informed consent to proceed with a less experienced physician is related to the duty to refer a patient to a more expert professional. If it was unreasonable for the physician to provide the service herself, the physician has breached her duty to refer. But even if it is not malpractice to provide the service one's self, the failure to advise the patient of the physician's lack of experience may violate the duty of obtaining the patient's informed consent.

Selected Legal Excerpts
Del Valle Rivera v. United States

"Plaintiffs further claim that sclerotherapy was not offered to this patient. Dr. Suau, not an expert on sclerotherapy by any means, defended the therapy, placed the same in use many years ago, and stated the same was available at the Puerto Rico Medical Center. Plaintiffs intimate that, in any event, the patient should have been transferred to the institution that could afford the treatment. The credible medical evidence is to the effect that sclerotherapy was experimented with many years ago as a medical curiosity and abandoned. In 1981-82, the same was being utilized on an experimental basis in some stateside medical centers....We conclude as a matter of fact that Juan Isidro Colon, a 49-year old male with a background of alcoholism, severe liver disease, diabetes mellitus, obesity, history of smoking, portal huypertension and esophageal bleeding varices, died as a result of the normal development of the disease....Here, all we can find is a hindsight analysis of medical record discrepancies or failures to record." (p.755-756)

Tunkl v. Regents of University of California

"In insisting that the patient accept the provision of waiver in the contract, the hospital certainly exercises a decisive advantage in bargaining. The would-be patient is in no position to reject the proferred agreement, to bargain with the hospital, or in lieu of agreement to find another hospital. The admission room of a hospital contains no bargaining table where, as in a private business transaction, the parties can debate the terms of their contract. As a result, we cannot but conclude that the instant agreement manifested the characteristics of the so-called adhesion contract. Finally, when the patient signed the contract, he completely placed himself in the control of the hospital; he subjected himself to the risk of its carelessness.

In brief, the patient here sought the services which the hospital offered to a selective portion of the public; the patient, as the price of admission and as a result of his inferior bargaining position, accepted a clause in a contract of adhesion waiving the hospital's negligence; the patient thereby subjected himself to control of the hospital and the possible infliction of the negligence which he had thus been compelled to waive. The hospital, under such circumstances, occupied a status different than a mere private party; its contract with patient affected the public interest. We see no cogent reason for according to the patron of the inn a greater protection than the patient of a hospital; ..." (p.447)

Colton v. New York Hospital

"The action for medical malpractice and loss of consortium arises from a kidney transplant operation performed at the New York Hospital on January 25, 1972, in which one of plaintiff Donne Colton's kidneys was removed and implanted in the body of his brother, Dudley Colton, Jr. Prior to the operation, the brothers executed an agreement with the Hospital denominated "Request for and Consent to Kidney Transplant and Covenant Not To Sue Upon and Release of All Claims". The sole issue now before the Court is the meaning and effect of the agreement.... [p.869]

"The inherent dangers of an experimental procedure include the reasonably foreseeable possibility that untoward consequences may occur....Whether or not a given injury was expected, or even foreseeable, is not an issue for the trier of facts. Rather any injury, whether foreseeable or not, is barred by the covenant, provided that it is a consequence of the non-negligent performance of the procedure...

...The issue of defendant's alleged failure to obtain plaintiff's informed consent was raised....The record before this Court belies this claim. Over a ten year span, Donne and his family were advised by numerous medical specialists who explained the mechanics of the procedure and its risks." (p.876)

Schneider v. Revici

"While we do not determine, in the case before us, whether Mrs. Schneider expressly assumed the risk of Dr. Revici's treatment, we hold that there existed sufficient evidence — in the language of the Consent for Medical Care form that she signed, and in testimony relating to specific consent informed by her awareness of the risk of refusing conventional treatment to undergo the Revici method — to allow the jury to consider express assumption of risk as an affirmative defense that would totally bar recovery." (p.996)

Johnson v. Kokemoor

The defendant is Dr. Kokemoor.

"As we stated in Martin v. Richards, 192 Wis.2d 156, 174, 531 N.W. 2d 70 (1995), "a patient cannot make an informed, intelligent decision to consent to a physician's suggested treatment unless the physician discloses what is material to the physican's decision, i.e., all of "the viable alternatives and risks of the treatment proposed." In this case, information regarding a physician's experience in performing a particular procedure, a physician's risk statistics as compared with those of other physicians who perform that procedure, and the availability of other centers and physicians better able to perform that procedure would have facilitated the plaintiff's awareness of "all the of the viable alternatives" available to her and thereby aided her exercise of informed consent." (p.498)
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