The plaintiff in Allen v Harrison , Case # 111877, 2016 OK 44 (4/19/2016), decided by the Oklahoma Supreme Court, had the following facts. On June 1, the patient swallowed a “small nail.” We don’t know how small, but the first thing that came to my mind was an errant piece of orthodontic archwire; hey, it happens. She went to the hospital emergency room, and the ER physician examined her, ordered an x-ray of her stomach, and saw the foreign body sitting in the stomach just below the diaphragm. Based on his experience and assessment of the patient’s clinical presentation and exercising due judgment, he released the patient, prescribing (1) “a high fiber diet to let the nail pass,” (2) a return to the hospital if she had any problems, and (3) a follow-up appointment with her family doctor in 3 days. The next day, June 2, after a bout of severe vomiting, she returned to the ER. Later that day, emergency surgery was performed to remove the nail (our wire) from her intestines because it had perforated the bowel resulting in a severe infection. She ultimately required 2 more surgeries to treat the resulting complications.
The patient then became the plaintiff, suing the doctor based on a claim of negligence and lack of informed consent. Specifically, she claimed that the ER doctor did not disclose the potential risks associated with attempting to let the nail pass and the other alternatives to his recommended treatment: endoscopic or surgical intervention, or referral. The ER doc stated that since he was not qualified to perform the endoscopy or surgery and since he didn’t recommend that course of therapy, he had no duty to disclose those options. He further argued that a claim for lack of informed consent in Oklahoma had to involve some affirmative form of treatment, and he had no duty to offer treatment that was outside his ability or scope of expertise, particularly if it was a treatment he believed was unwarranted. He had done what he thought was proper under the circumstances, allowing for the possibility that further treatment might be necessary by advising the plaintiff that if any further symptoms developed she should return to the hospital where alternative treatments could be rendered. The trial court agreed, noting the following.
[T]he Court can find no case supporting the doctrine of informed consent where no action was taken by the attending physician. Rather, such doctrine applies when the treatment received causes injury, and alternative procedures were not explained. Plaintiff’s claim is one of negligence based upon Defendant’s failure to appropriately recognize and treat… [her] symptoms.
The informed consent claim was dismissed, but the trial continued on the negligence claim. In the end, the jury returned a verdict for the defendant doctor. The case was appealed. The appellate court affirmed the trial court’s ruling by holding that the doctrine of informed consent does not even come into play unless surgical treatment is rendered resulting in injury, and the alternatives to surgery were not divulged. The case was then appealed to the Oklahoma Supreme Court. It reversed both lower courts’ findings for the plaintiff and remanded the case for further proceedings based on the following reasoning and findings.
The court began by noting that “each man is considered to be his own master.” Given that premise, a patient can only be his own master if he is given enough information to enable him to make an informed choice, thus determining his own course of treatment. Oklahoma previously used the professional standard of informed consent: a physician was allowed to substitute his judgment for that of the patient (proceeding in what he determined to be the patient’s best interests). However, that standard of care was overturned in 1979 when the patient self-determination standard was invoked. This doctrine of informed consent is used by most states today and essentially holds that a doctor’s duty is to (1) “inform a patient of the medically reasonable treatment options and their attendant risks,” (2) “present the medical facts accurately to the patient or his proxy and to make recommendations for management in accordance with good medical practice,” (3) “disclose all courses of treatment that are medically reasonable under the circumstances,” (4) “not withhold any facts which are necessary to form an intelligent consent by the patient to the proposed treatment,” and (5) “not only disclose what he intends to do, but supply information which addresses the question of whether he should do it.” Not performing any of these facets would expose the practitioner to liability for any consequences stemming from the nondisclosure.
The court then noticed the uniqueness of the question being presented. Must informed consent be obtained if the doctor is recommending noninvasive treatment? The court began its answer by stating that the real question doesn’t revolve around invasive vs noninvasive treatment. The real issue, the only issue, is whether the patient received enough information to enable her to make an informed and intelligent choice about her medical needs and options. The court noted the following.
As a practical matter, a physician will recommend a course of treatment and a patient generally chooses to adopt the physician’s recommendation. It is well-settled that the ultimate decision rests with the patient. Therefore, physicians do not adequately discharge their obligations by limiting their disclosures to the treatments they recommend or treatments within their scope of practice.
… In examining the seminal cases shaping the informed consent doctrine, it is patently clear a physician has a duty to inform the patient not only of the medically reasonable alternatives the physician recommends, but of medically reasonable alternatives that the physician does not recommend to the patient or disclose… The doctrine applies equally to invasive, as well as noninvasive procedures. And, any other interpretation belies the fundamental premise that “each man [is] considered to be his own master.” At a minimum, Physician should have explained to Allen the associated risks and the alternatives to letting the nail pass through her digestive system along with his reasons for the recommended course of treatment.
Noting that physicians cannot be allowed to “perpetuate medical paternalism by giving the medical profession sweeping authority to decide unilaterally what [is] in the patient’s best interests”… since this would “severely limit the protections granted to an injured patient and jeopardize a patient’s right of self-determination,” the court then addressed the ER doc’s claim that he didn’t affirmatively treat the patient. Dismissing this argument, the court noted that, in Oklahoma, treatment is defined as “the use of drugs, surgery, including appliances manual or mechanical means, or any other means of any nature whatsoever, for the cure, relief, palliation, adjustment or correction of any human ill.” Recommending to a patient to “eat fiber and let the nail pass” unquestionably falls under this definition because it is a form of treatment.
The court concluded that the defendant, after reviewing the x-rays, determining the position of the small nail (our wire), and noting that it had cleared the diaphragm, then made a medical decision to let the foreign object pass. He admitted that endoscopy or surgical intervention was a medically viable alternative and that he did not disclose this information to the plaintiff. Regardless of his level of experience or training, and the facts that it was outside the scope of his practice and would have required referrals to other practitioners, it was precisely the type of information that he should have disclosed to the plaintiff because it would have enlightened her about the alternatives that she was entitled to know. Since he chose to treat the patient in this manner, he was not within his purview even if it was his preferred method of treatment for the clinical situation. The ultimate decision must rest with the patient.
Yes, I’ve had patients who swallowed small pieces of wire. Maybe not the size of a “small nail,” but what’s a millimeter or two between friends? There are, by the way, some very small nails out there. Over the decades, my patients have swallowed brackets, a band, some small pieces of excess bonding material and cement chipped off a tooth, a tooth itself, a few elastomeric ligatures and rubber bands (I figured the only downside was that it would put a spring in their step), and some small pieces of ligature wire. Did I send them for abdominal x-rays? Only once, because the patient’s mother was beside herself; the kid had swallowed a bracket. What did I do with the rest of them? I told the parents that whatever was swallowed would pass within 3 days. They were free to examine the patient’s stool every day to check on the progress of the expulsion of whatever it was, but I couldn’t do that because it was outside my scope of practice. We’d giggle and that was that. I offered to pay for x-rays (although I couldn’t recommend the unnecessary radiation exposure), but except for that 1 time, no one ever took me up on it. All of the foreign bodies mentioned above passed. Well, I guess they passed because no one ever got sick, and nobody ever sued me.
When it was a band (only once), I did recommend that there was a surgical option to go after it because there was always the possibility that it could get hung up in the intestinal tract and cause a problem (it didn’t). There was this one time, however, when I was running a residency program. I wasn’t there that day, and a junior faculty member was overseeing treatment. The patient swallowed a bracket. The discussion included the options of letting it pass and a trip to the ER. The patient’s mom decided to be safe and go to the hospital, although the patient was in no obvious distress. However, as the fates would have it, this didn’t occur in June; it occurred in July.
If you are familiar with hospital residency programs, you should already have a sinking feeling in the pit of your stomach. All residency programs start July 1. The new guys come in and replace the experienced guys who left on June 30. The ER resident, a newbie, called in a gastro resident for a consultation; he was also a newbie. In their collective infinite wisdom, they decided that an endoscopic procedure to retrieve the bracket was the way to go. Wanna guess what happened? Gotcha, nothing happened. They retrieved the bracket and all was well with the world, and nobody got sued. But there didn’t have to be a happy ending. All sorts of things could have gone wrong with a procedure that wasn’t necessary.
But, and here’s the thing, the patient was told about each viable alternative, and the patient made the decision. Okay, it was her mom who made the decision, but patient autonomy was respected. The high road was followed; the sun came out, and the sky was blue. It could’ve been a cloudy day, but it turned out okay. When I look back on those events, I suppose that on just the wrong day it could have turned out different. No, I don’t mean there could have been a surgical mishap; sure, that could have happened. No, I mean it could have turned out exactly like this case. The patient could have chosen to let it pass, the offending piece of whatever could have gotten hung up in the intestinal tract, it could have caused an infection requiring surgery that could have had its own negative consequences, it could have resulted in the need for subsequent surgical procedures, and yes, my junior faculty member could have been sued. But of course, this whole doom-and-gloom scenario might just be a pipe dream because in this little fact pattern there is a difference. The patient was given the options of letting it pass and having an endoscopy. See what difference a little autonomy makes?
Bottom line? Whether it’s going after foreign bodies or not, extracting premolars or not, using orthopedic appliances or not, accelerating treatment or not, it makes no difference. If there are viable options to address whatever the situation is, whether you do them or not, whether you believe in them or not, whether you are good in them or not, there is 1 commonality. Because they are viable options, you must let the patient decide. It doesn’t mean that you can’t try to direct him toward the choice you think is best. You can, but you must offer the choices so that the patient can decide and become, Seinfeld aside, “the masters of our domain,” our own fate. This is what informed consent is all about.
Oh, 1 last thing and then I’ll button up. That little part about trying to direct them to the option that you believe is best. This is a slippery slope. There is a fine line between patient education and coercion. If we’re not careful, we can overeducate our patients to the point where we have tipped the scales and vitiated their autonomy. Yea, it’s tough out there, but that’s why you get paid the big bucks.