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Informed consent claim need not be proved with statistical evidence

Statistical evidence of probability of a risk is not necessary to show a patient has not been informed of a material fact needed for informed consent, the Court of Appeals ruled in Collins v. Juergens Chiropractic, PLLC, No. 52552-6-II (Jul. 8, 2020). Nor is it necessary to show the probability is above a certain minimum percentage to survive summary judgment.

In that case, a patient who suffered a stroke sued his chiropractor. He alleged that a cervical manipulation caused his stroke, that the chiropractor failed to perform a full pretreatment work-up, and that the chiropractor had not disclosed the risk of stroke from this type of manipulation. The plaintiff asserted causes of action for negligence and lack of informed consent, two distinct legal theories under the medical malpractice statute, RCW 7.70.030. The chiropractor prevailed on summary judgment on both claims, and the patient appealed.

As to the negligence claim, the patient was able to raise a genuine issue of material fact on the elements of appropriate standard of care and breach. His medical experts opined that a reasonable chiropractor in this circumstance would have performed a pretreatment workup that included recent X-rays, a comprehensive exam, and screening the patient for risk of stroke and other vascular injuries.

However, the Court of Appeals affirmed summary judgment on the element of proximate cause. The patient had provided no expert testimony that the omitted pretreatment workup would have revealed any factor suggesting that the treatment should not be attempted. Therefore, he lacked evidence that the alleged negligent pretreatment workup had caused the stroke. The court rejected the plaintiff’s argument that the burden of proof should shift to the chiropractor on this element, such that he would have to prove pretreatment workup would not have revealed the manipulation was contra-indicated.

On the other hand, the court reversed summary judgment on the informed consent claim, which requires proof that the plaintiff did not know of a “material fact.” Materiality is determined by (1) establishing through expert testimony the existence of a risk, its likelihood, and the type of harm in question; then (2) deciding whether a reasonably prudent person would attach significance to that risk in deciding whether to undergo the available treatment.

The likelihood of harm was the factor at issue in the first part of the materiality analysis. The chiropractor had admitted that the patient had not been warned of the risk of stroke, and that stroke was a serious harm. He argued that likelihood of stroke occurring was very small. The patient’s expert had cited studies putting that probability at varying levels, the highest being 0.104 percent. The chiropractor argued the evidence demonstrated the risk was not material and need not have been disclosed. He argued the patient must present statistical evidence the risk was significant, not only expert testimony that did not quantify the probability that the treatment would cause stroke.

The court rejected the argument that statistical evidence is necessary to support magnitude of risk of harm. It did acknowledge that vague statements that a risk is “material” or “significant” are conclusory and invade the province of the fact-finder. The court also rejected the chiropractor’s argument that a risk is not material as a matter of law unless it is above a certain percentage, and disagreed with prior cases so holding. In this case, the patient’s expert cautioned that he believed the risk is grossly underreported, leading to unrealistically low numbers in the available studies. He opined the risk was heightened in cases like this one, where the chiropractor performed a vigorous and rotational manipulation. The expert’s testimony was sufficient to survive summary judgment.

For the second part of the materiality analysis, the relevant inquiry is what a reasonably prudent patient under similar circumstances – not the party to the lawsuit – would have done. The patient’s testimony that he would have chosen not to have a rotational manipulation if he had been informed of the risk of stroke is relevant and admissible, but it is not dispositive. The evidence that he had two to three additional risk factors for stroke was enough to raise a genuine issue of material fact that a reasonably prudent person in his position would have chosen one of the safer treatment options if they had been informed of the risk.

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