Sard v Hardy, 379 A.2d 1014 (Md Ct App, 1977) is one of the best cases to read for anyone wanting to understand what the doctrine of informed consent is all about. The facts are relatively simple. The plaintiff had a tough pregnancy, developing eclampsia toward the later part of her term. A spiraling set of adverse medical complications ensued, requiring a premature cesarian section (C-section) to save the life of both mother and child. Unfortunately, the child was stillborn

Her next pregnancy went well, and she delivered a healthy baby, again by C-section. A short time after that, the plaintiff was again pregnant for the third time. During her prenatal care with her obstetrician, the plaintiff was told and was presented with the following information in writing that a fourth pregnancy would imperil her health and could result in death and that because of this, the recommended medical options were sterilization via a tubal ligation sometime after completion of the C-section, oral contraception, or the use of an intrauterine device. A vasectomy for the patient’s husband was not discussed.

This was fine with the plaintiff as she had expressed to her doctor that she did not want to have more children anyway; as her pregnancies had been difficult, she was not willing to risk losing another child, and besides that, she did not have the financial resources to raise any more kids. Both doctor and patient decided to perform the tubal ligation at the same time as the C-section instead of waiting until some later date after the surgical site had healed to prevent another exercise of her fertility talents from occurring. What was not discussed was the increased failure rate of tubal ligations when done at the time of a C-section as opposed to waiting until a later postsurgical date. As fate would have it, the tubal ligation failed, and the patient became pregnant for the fourth time and had to undergo another C-section, which resulted in the birth of the plaintiff’s third live child. The plaintiff sued, claiming lack of informed consent and breach of warranty.

As an aside, the 6 most common methods for performing a tubal ligation are the Madlener and the Pomeroy techniques, as well as the Irving, Uchida, Aldridge, and Erlich methods. The evidence at trial revealed that during the third C-section, the defendant used the Madlener technique, which was the simplest of all 6 to accomplish when performed in association with a C-section. However, it also carried the highest risk of failure, 2%. Evidence also revealed that had the Uchida or Irving methods been used, the chance for the tubal ligation failing would have only been 0.01%. While waiting to be wheeled into the delivery room for her second delivery but third pregnancy, the plaintiff was handed a form to read and sign that read:

I/We understand what is meant by sterilization and I/We understand that if this operation is successful, the above named patient will be unable in the future to produce children, but I/We understand that an operation intended to effect sterilization is not effective in all cases.

At trial, the defendant testified that the standard of care did not require physicians to discuss the various surgical technique options with the patient, nor the risks associated with each option, as it was not until the patient was on the operating table and the abdomen opened that the surgeon could visualize the anatomy and condition of the uterus, thus determining which procedure to use. Nor was it the habit of other practitioners to discuss the potential for the procedure to be unsuccessful, thus resulting in another unwanted pregnancy.

The jury in the trial court decided in favor of the defendant physician, and the plaintiff appealed. The appellate division court reached the same conclusion, finding that the standard of care required the doctor to disclose what facts he believed the patient needed to know, as was done in the present case. It also determined that a 2% chance of a negative happenstance did not rise to the level of being materially important. Finally, the court noted that the plaintiff had provided no proof that had she been informed of all of the facts; she would have acted any differently. As expected, this decision was then appealed to the Maryland State Court of Appeals.

The first note of importance in their decision was the court making the distinction between obtaining a patient’s consent as opposed to obtaining informed consent. The court stated

The doctrine of informed consent, which we shall apply here, follows logically from the universally recognized rule that a physician, treating a mentally competent adult under non-emergency circumstances, cannot properly undertake to perform surgery or administer other therapy without the prior consent of his patient.

In order for the patient’s consent to be effective, it must have been an “informed” consent, one that is given after the patient has received a fair and reasonable explanation of the contemplated treatment or procedure.

The court then began its informed consent analysis by quoting holdings from other courts around the country that had dealt with this issue. These decisions noted that when dealing with elective surgery or in nonemergent situations regarding claims for lack of informed consent:

[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body.

…the doctrine of informed consent takes full account of the probability that, unlike the physician, the patient is untrained in medical science, and therefore depends completely on the trust and skill of his physician for the information on which he makes his decision.

Simply stated, the doctrine of informed consent imposes on a physician, before he subjects his patient to medical treatment, the duty to explain the procedure to the patient and to warn him of any material risks or dangers inherent in or collateral to the therapy, so as to enable the patient to make an intelligent and informed choice about whether or not to undergo such treatment.

This duty to disclose is said to require a physician to reveal to his patient the nature of the ailment, the nature of the proposed treatment, the probability of success of the contemplated therapy and its alternatives, and the risk of unfortunate consequences associated with such treatment.

The law does not allow a physician to substitute his judgment for that of the patient in the matter of consent to treatment….

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. Likewise the physician may not minimize the known dangers of a procedure or operation in order to induce his patient’s consent. (Cits. Omit.)

The court then delved into areas familiar to every law student, but these legal concepts happen to be just as important to clinicians practicing everywhere. The first area dealt with recognizing which standard of care to apply. In the United States, there are 2 main philosophical approaches. The minority approach, which used to be the majority approach until a shift occurred in the 1960s, used the Professional Standard, which, as it happened, was the law in Maryland at the time this case was tried. This approach was based on the principle that a physician could rely on his professional skill and judgment in determining the degree of information that needed to be disclosed to a patient and that the degree of information needing to be disclosed should be measured against the degree of information disclosed by similarly trained practitioners dealing with the same malady under the same or similar conditions and circumstances. Proponents of this approach believed it to be the preferred method for disclosure since

…only a physician is capable of estimating the potential psychological impact that risk disclosure would have on a particular patient.

…in deciding whether and how much to disclose prior to treatment, a medical practitioner must consider the state of his patient’s health, the condition of his heart and nervous system, his mental state, and whether the risks involved are mere remote possibilities or hazards which occur with more appreciable regularity.

…to hold physicians to a general standard of care with respect to disclosure would interfere with the flexibility a doctor must have in determining what therapy would best suit his patient’s needs. (Cits. Omit.)

Over time, normative bioethical principles started competing with this Professional Standard, and so most jurisdictions moved toward using the Lay or Patient Need to Know Standard. This shift in thinking was spurred on by the concept that the core duty of physician disclosures must be governed by a reasonable patient’s informational needs if they are to have the autonomy to decide whether to accept or reject a proposed course of therapy. In other words, it is not what the physician thinks the patient should know; it is what the patient decides the need to know to make an intelligent and informed decision. One overriding argument against using the Professional Standard was that it seemed akin to having the fox guard the henhouse. As noted by one court:

Unlimited discretion in the physician is irreconcilable with the basic right of the patient to make the ultimate informed decision regarding the course of treatment to which he knowledgeably consents to be subjected . (Cit. Omit.)

In overturning Maryland’s Professional Standard and adopting the Lay or Patient Need to Know Standard, the court then went on to address the underlying basis supporting that doctrine of informed consent, as well as defining what information is considered material by stating

…since the patient must suffer the consequences, and since he bears all the expense of the operation and postoperative care, fundamental fairness requires that the patient be allowed to know what risks a proposed therapy entails, alternatives thereto, and the relative probabilities of success.

A material risk is one which a physician knows or ought to know would be significant to a reasonable person in the patient’s position in deciding whether or not to submit to a particular medical treatment or procedure.

Whether a physician has fulfilled his duty to disclose, then, is to be determined by reference to a general standard of reasonable conduct and is not measured by a Professional Standard of care. (Cits. Omit.)

The next obvious question for the clinician is how do I know how much information I need to disclose to a patient? The court was quite succinct by holding that a “…physician need not deliver a lengthy polysyllabic discourse on all possible complications. A mini-course in medical science is not required.” The easiest way to interpret this is to put yourself in the position of a patient facing a significant medical issue and ask yourself, what material information would you need to know to accept or reject whatever course of therapy was being proposed?

The follow-up to this proposition would naturally be whether any exceptions exist that negate the duty to disclose certain information, even if such information is deemed material. Once again, the court was quite clear: doctors are permitted to withhold disclosure of material information on therapeutic grounds. In this type of scenario, if the doctor decides that complete and candid disclosure of a procedure’s risks, as well as those risks pertaining to viable alternative treatment therapies, “…could have a detrimental effect on the physical or psychological well-being of the patient,” then therapeutic privilege could be asserted as an affirmative defense to a claim for lack of informed consent. Other defenses noted by the court include situations in which a patient is incapable of granting legally valid consent because they are mentally incompetent, are a minor, or have specifically requested that they not be informed. In addition, the obligation to obtain a patient’s informed consent would not apply in certain types of emergencies or when a patient is physically unable to do so, such as being in an unconscious state. The last 2 defenses occur in situations in which the risks of undergoing the procedure are either already known to the patient because of prior experience, when the risks are so obvious or are assumed to be so generally known that they need not be discussed, or when the risk is so rare, remote, or unknown to the specialty that requiring disclosure would be akin to requiring one to know of and discuss the unknown. The above are merely defensive arguments as to why disclosure was not performed, and it is for the jury to decide whether the standard of care was adhered to or not; and if it was not, did a legally acceptable reason exist for not doing so?

The court still had 3 more issues to decide, the first being whether expert testimony is required when using a Lay or Patient Need to Know Standard. In dismissing the Professional Standard, the court stated:

If the foundation of the doctrine of informed consent is the patient’s right to know and his right to physical self-determination, then logic requires that the standard of care applicable to physicians in disclosure cases not be drawn from medical practice and custom. (Cit. Omit.)

Opining as to why expert testimony is required in states using the Lay approach, the court opined:

…expert testimony would be required to establish the nature of the risks inherent in a particular treatment, the probabilities of therapeutic success, the frequency of the occurrence of particular risks, the nature of available alternatives to treatment and whether or not disclosure would be detrimental to a patient. (Cit. Omit.)

The second issue concerns the element of proximate causation. For any plaintiff to succeed at trial, they must prove the 4 elements that make up a claim for medical negligence. The first is that there was some duty or standard of care that a practitioner is required to adhere to; the second is that the doctor breached that duty in some manner; the third is that the patient experienced a compensable injury; but the most important element is the final one, that being that the injury sustained had to be directly or proximately caused by the breach of the duty owed the patient. The court said it this way:

The rule is that a plaintiff cannot recover under the doctrine unless he can prove by a preponderance of the evidence that he would not have given his consent to the proposed procedure had full and adequate disclosure been made at the time consent was originally given.

Of course, the skeptics among us would now posit the question, “How do I know what any one particular person would deem material? There is no way for me to get inside of everyone’s head, their value systems, their beliefs, their fears, what have you.” The skeptics have a point, and there are very few jurisdictions that use a subjective test. Fortunately, almost all states employing the Lay Standard use an objective test. The court addressed it as follows:

With respect to the proximate cause requirement, the principal dispute centers on whether causality is to be judged by a subjective test—what the patient himself would have done had adequate disclosure been made—or an objective test—what a reasonable person in the patient’s position would have done had he been fully informed.

Better it is, we believe, to resolve the causality issue on an objective basis: in terms of what a prudent person in the patient’s position would have decided if suitably informed of all perils bearing significance. If adequate disclosure could reasonably be expected to have caused that person to decline the treatment because of the revelation of the kind of risk or danger that resulted in harm, causation is shown, but otherwise not. (Cits. Omit.)

The final issue for the court dealt with the patient’s claim that the doctor verbally assured the patient that “after the operation she would not be having any more children” and whether this statement rose to the level of creating an express warranty. As a general rule, various courts have noted the following:

An alleged express warranty cannot be enforced as a warranty unless (1) it was made before the operation was performed and was relied on by the patient in contracting for the service, or (2) it was supported by a separate consideration.

…a physician is not an insurer of the success of his treatment and absent an express agreement, does not warrant or guarantee that he will effect a given result.

…considering the unpredictability of medical results and the differences in individual patients, it is unlikely that the physician of integrity can in good faith promise a particular outcome. Also, some patients are prone subjectively to transform hopeful expressions of opinion into hard promises, particularly following an undesirable result. (Cits. Omit.)

The problem, of course, hinges on whether or not a warranty of some sort was actually made by the doctor to the patient as opposed to the habit that almost every health practitioner engages in, which is using words, terminology, and verbiage that is tantamount to therapeutic reassurance, hopeful expressions of opinion, or mere predictions of outcome based on clinical experience. The court decided to enact a hybrid ruling by holding that when a claim for breach of warranty is made preoperatively, the plaintiff must have actual proof of such expression, but if the warranty is made postoperatively, it requires the accompaniment of additional consideration (an additional fee) to support the promise. The court cited a holding from another jurisdiction supporting their rationale for this hybrid approach.

The law has taken the middle of the road position of allowing actions based on alleged contract, but insisting on clear proof . Instructions to the jury may well stress this requirement and point to tests of truth, such as the complexity or difficulty of an operation as bearing on the probability that a given result was promised. (Emphasis in original)

We, too, adopt the rule that although a patient may recover for breach of an express, pre-operative warranty to effect a particular result, despite the absence of a separate consideration, he may do so only upon proving by clear and convincing evidence that the physician did, in fact, make the alleged warranty. (Cit. Omit.)

The court, finding no clear and convincing proof that the defendant made any express warranty, dismissed that part of the plaintiff’s claim; however, it reversed the holding of the lower 2 courts on the informed consent issue and remanded the case for a new trial using the newly adopted Lay or Patient Need to Know Standard.