How much is too much?

At trial, when attempting to determine whether a patient’s informed consent was obtained, is it appropriate for the jury to hear all of the risks that should have been disclosed or only those that actually materialized and resulted in injury? From a clinical perspective, the answer is this: since you don’t know which of any potential risks will actually occur, one needs to discuss all of them with the patient to truly inform the patient. But what if we ask the same question, only this time from the legal perspective? Suppose there are many potential things that can go wrong, as in orthodontics. You know, root resorption, caries, decalcifications, periodontal breakdown, roots perforating the alveolar process, and the list goes on (just read your informed consent form). Now suppose that 1 or 2 of them materialized, causing injury to the patient. At trial, would you want the jury to know that you told the patient about everything that could go wrong or just the things that actually occurred? Would you want the jury to know about all of the negative possibilities, thus magnifying the danger of treatment, or would you just want them to hear “I told the patient that this might happen and it did; the patient knew and acknowledged the risk.” That’s what White v. Beeks (Ct. App. Tenn., No.E2012-02443-COA-R3-CV, 12/9/2013) was all about.

The plaintiff had a herniated disc. The defendant performed spinal surgery using a product called “InFuse,” a bone morphogenic protein designed to stimulate bone growth and promote bony fusion. Unfortunately, it worked too well. The plaintiff developed excess bone in his spine that irritated a nerve root, resulting in a significant injury. Obviously, the patient sued. At his deposition, the plaintiff’s expert testified that InFuse has been known to cause (1) cystic lesion formation in the spinal canal, (2) postoperative fluid buildup within the spinal canal requiring further treatment, (3) ectopic or excessive bone growth, and (4) inflammation around the nerve roots. At the trial, the defendant filed a motion with the court to preclude the plaintiff’s expert from discussing any potential complications other than the ones actually sustained by the patient; this motion was granted. The jury ultimately found for the defendant, the plaintiff motioned for a new trial, the court rejected the motion, and this appeal ensued. The issue on appeal was whether the trial court erred when it limited the expert’s testimony to only the risks that actually caused the plaintiff’s injury. The appellate court, in an excellently written opinion, proceeded to outline the law on this subject.

The relevant statute, Tenn. Code Ann. Sec 29-26-118, dealing with informed consent, states: “that the plaintiff shall prove … that the defendant did not supply appropriate information to the patient in obtaining informed consent … in accordance with the recognized standard of acceptable professional practice in the profession and in the specialty … in the community in which the defendant practices and in similar communities.”

The court then stated why practitioners have the obligation to obtain a patient’s informed consent and, in addition, what elements are needed to comply with this requirement by quoting from a number of case decisions from various jurisdictions across the country. The court first noted the following.

A cause of action based on the lack of informed consent stems from the premise that a competent patient should be allowed to formulate an intelligent, informed decision about surgical or other treatment procedures the patient undertakes. The basic policy consideration which supports the recognition of the cause of action for lack of informed consent has been explained as follows:

The root premise is the concept fundamental in American jurisprudence that “every human being of adult years and sound mind has a right to determine what shall be done with his own body….” True consent to what happens to one’s self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks dependent upon each. The average patient has little or no understanding of the medical arts, and ordinarily has only his physician to whom he can look for enlightenment with which to reach an intelligent decision. From these almost axiomatic considerations springs the need, and in turn the requirement, of a reasonable divulgence by [the] physician to [the] patient to make such a decision possible.

Accordingly, the law recognizes that a health care provider, such as a physician or surgeon, who proposes a treatment or surgical procedure has a duty to provide the patient with enough information about the nature of the treatment or procedure involved to enable the patient to make an intelligent decision and thereby give an informed consent to the treatment or procedure. Depending on the usual and customary advice given to patients to procure consent in similar situations, the health care provider must typically inform the patient of the diagnosis or nature of the patient’s ailment, the nature of and the reasons for the proposed treatment or procedure, the risks or dangers involved, and the prospects for success. The patient must also be informed of alternative methods of treatment, the risks and benefits of such treatment and, if applicable, that the proposed treatment or procedure is experimental. Whether the information given to the patient is sufficient “depends on the nature of the treatment, the extent of the risks involved, and the standard of care [applicable to the defendant health care provider].”

After the court provided the “why” for informed consent, it addressed the nuts and bolts of “how” a defendant proves that informed consent was obtained from a legal perspective by noting the following.

In matters of informed consent the plaintiff has the burden of proving by expert medical evidence, (a) what a reasonable medical practitioner in the same or similar communities under the same or similar circumstances would have disclosed to the patient about the attendant risks incident to a proposed diagnosis or treatment and (b) that the defendant departed from the norm.

… Causation in informed consent cases is better resolved 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.

The finder of fact may consider and give weight to the patient’s testimony as to whether the patient would have consented to the procedure upon full disclosure of the risks. When applying the objective standard, the finder of fact may also take into account the characteristics of the plaintiff including the plaintiff’s idiosyncrasies, fears, age, medical condition, and religious beliefs. Accordingly, the objective standard affords the ease of applying a uniform standard and yet maintains the flexibility of allowing the finder of fact to make appropriate adjustments to accommodate the individual characteristics and idiosyncrasies of an individual patient. We, therefore, hold that the standard to be applied in informed consent cases is whether a reasonable person in the patient’s position would have consented to the procedure or treatment in question if adequately informed of all significant perils.

Causation and proximate cause are distinct elements of negligence, and both must be proven by the plaintiff by a preponderance of the evidence. Causation (or cause in fact) is a very different concept from that of proximate cause. Causation refers to the cause and effect relationship between the tortious conduct and the injury. The doctrine of proximate cause encompasses the whole panoply of rules that may deny liability for otherwise actionable causes of harm. Thus proximate cause, or legal cause, concerns a determination of whether legal liability should be imposed where cause in fact has been established. Cause in fact, on the other hand, deals with the “but for” consequences of an act. The defendant’s conduct is a cause of the event if the event would not have occurred but for that conduct.

The court then addressed the issue that was at the heart of the appeal in the case at hand with the following.

No more than a breach of any other legal duty does nonfulfillment of the physician’s obligation to disclose alone establish liability to the patient. An unrevealed risk that should have been made known must materialize, for otherwise the omission, however unpardonable, is legally without consequence. Occurrence of the risk must be harmful to the patient, for negligence unrelated to injury is nonactionable. And , as in malpractice actions generally, there must be a causal relationship between the physician’s failure to adequately divulge and damage to the patient. A causal connection exists when, but only when, disclosure of significant risks incidental to treatment would have resulted in a decision against it.

[F]ailure to inform a patient of a risk that does not ripen into a condition as a result of the surgery is immaterial as to whether informed consent was given. In such a situation, no injury equals no cause of action. The critical question is what, if anything, was required to be said, and what was said, about the condition that did result from the surgery .

This is not to suggest … that a health care provider is required to enumerate in detail every aspect of the proposed treatment or procedure or discuss every possible thing that might go wrong in an effort to obtain the patient’s informed consent. In the first place, to do so is humanly impossible. In the second place, if all the gory details of a proposed surgery were graphically explained to every patient and all possible medical maladies that might result were enumerated we doubt that a lay person would have the stomach to listen to it all; and if the patient did, would probably be in such a fearful state that no rational decision could be made. (cits. omit.) (Emphasis in original)

The appellate court agreed with the ruling of the trial court and upheld the verdict for the defendant.

Commentary

What do we actually need to tell patients? Look at it this way. If you didn’t know squat about orthodontics, and you were about to plunk down 5 grand to have braces for 2 years, what would you want to know? Would you want to know whether anything could go wrong, and if it did, what the consequences could be? Of course you would. Would you want to know absolutely everything and anything that could possibly happen? Probably not, but you surely would want to know about the stuff that could be meaningful: the stuff that could hurt you physically and fiscally.

The American Association of Orthodontists has a good informed consent document. My problem with it is that it hasn’t kept up with some of the changes in clinical orthodontics. There are at least 3 areas of concern that should be addressed when a rewrite is considered. Until then, separate informed consent forms for these issues can be used.

The first concerns lasers. Many of us are using lasers for soft-tissue procedures in our offices. The obvious risks concern inadvertent burns of surrounding soft and hard tissues as well as ocular injury. The second is the use of temporary anchorage devices and the potential for inadvertent injury from improper placement or attempting to address skeletal problems with a nonsurgical approach that ignores the limitations in any given case. The last, and possibly of greater importance, is the fact that many of us for a lot of reasons are engaging more and more in providing limited treatment. Patients need to know in no uncertain terms that only ABC will be treated, that XYZ will not be addressed, and what the potential consequences are from this decision.

Think of it this way. If you don’t tell patients about “whatever,” and “whatever” happens, when you try to explain later that this was just one thing that happens every now and then, blah, blah, blah, you are making excuses ex post facto. You are doing the old soft shoe and trying to dance your way out of it. If, on the other hand, you tell a patient that XYZ might happen and it does, you are a prophet, a visionary who can see into the future, and you have prepared them for what was to come. Do you want to be the explainer or the soothsayer? Which of those 2 people do we want the jury to look at when we are seated at the defendant’s table?

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Apr 6, 2017 | Posted by in Orthodontics | Comments Off on How much is too much?
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