By Alex Stein
Proving decision-causation in a suit for informed-consent violation is never easy. Things get even worse when a trial judge misinterprets the criteria for determining – counterfactually – whether the patient would have agreed to the chosen treatment if she were to receive full information about its benefits, risks, and alternatives. The recent Tennessee Supreme Court decision, White v. Beeks, — S.W.3d —- 2015 WL 2375458 (Tenn. 2015), is a case in point.
A patient with severe back pain underwent a lower back surgery. To stabilize the patient’s spine, his surgeon fused discs and joints by using the bone-grafting product InFuse: a human-engineered bone morphogenic protein, designed to stimulate bone growth and promote fusion. The patient’s condition initially had improved, but his pain came back. Subsequent tests revealed that he developed an abnormal bone growth and inflammations at the site of the surgery.
The patient sued the surgeon for informed consent violation and the case went to trial. The patient called an expert witness to testify that the surgeon should have informed him about the following risks associated with InFuse: abnormal bone growth, inflammations, cystic lesions, radiculitis, and fluid collection. The trial court, however, ruled that the expert could only testify about the materialized risks – abnormal bone growth and painful inflammatory reactions – about which the patient received enough information. The court reasoned that the remaining three risks were not relevant because neither of them materialized in the case at bar. Expectedly, the jury returned a verdict in the surgeon’s favor.
The trial court’s ruling was a product of a common – and yet, fairly basic – misunderstanding of decision-causation. Assume, for simplicity, that the five risks that the surgeon had to inform the patient about were mutually independent and that each of them materialized in 20% of the cases, causing damage in the amount of 1000. Under these assumptions, the patient’s expected harm equaled 20%×1000×5=1000. Hence, the patient would agree to undergo an InFuse procedure only when his expected benefit exceeds 1000.
Assume now that the surgeon informed the patient about two risks instead of five, as attested by the patient’s expert. This misinformation made the patient believe – mistakenly – that his expected harm from the InFuse treatment was 400 rather than 1000. If so, then the patient may have agreed to undergo the InFuse treatment because he estimated that it would yield him a benefit of 500. Had the patient known that his expected harm equals 1000, he would have chosen to decline the treatment. For that simple reason, the trial court should have admitted the testimony of the patient’s expert.
Luckily, the Tennessee Supreme Court fixed this fundamental mistake. The Court ruled that a patient needs to be informed of all “perils bearing significance” in order to give informed consent (citing Ashe v. Radiation Oncology Assocs., 9 S.W.3d 119, 122 (Tenn. 1999)) and that “perils bearing significance” necessarily include all perils: those that materialized and those that did not. In the Court’s words, “The fact that a risk did not materialize it does not make it less of a risk. At the time a patient is making a decision whether to undergo a medical procedure, he needs to know prospectively the risks he is facing — not just those risks that in hindsight materialized and caused him harm. The fact that a risk did not materialize during or after surgery is not a determining factor in whether it should have been disclosed to a patient before surgery.”
The Court remanded the case for a new trial on the issue of informed consent consistent with its holding.