A recent informed consent case provided the Supreme Court with the opportunity to analyze what risks a plaintiffs’ expert should be allowed to testify about at trial. In White v. Beeks, No. E2012-02443-SC-R11-CV (Tenn. May 18, 2015), plaintiff had undergone spinal fusion surgery after other attempts at pain management were unsuccessful. After the surgery, plaintiff’s pain initially improved but then became worse, and plaintiff alleged that this was because of an ectopic bone growth caused by the surgery. Plaintiff filed suit against defendant doctor asserting that the doctor had not given him adequate information before the surgery to enable him to give informed consent. Specifically, plaintiff alleged that the doctor failed to inform him that a bone mass product called InFuse would be used, how such product would be used, or the risks associated with InFuse.
To prove his informed consent case, plaintiff needed to “prove by expert testimony 1) the information that [defendant] should have disclosed to [plaintiff] to obtain his informed consent for the surgery, as established by the recognized standard of acceptable professional practice in the specialty [in the same or similar community], 2) whether [defendant] disclosed appropriate information to [plaintiff] to comply with the [standard of care], and 3) whether a reasonable person in [plaintiff’s] position would have consented to the surgery if he had been provided with the information required by the recognized acceptable professional practice.”
In his deposition, plaintiff’s expert testified regarding his opinion of the risks that were required to be disclosed to allow plaintiff to give informed consent for the procedure. Plaintiff’s expert stated that the risks of InFuse included ectopic bone growth, inflammatory reactions including cyctic lesions, and in 15-20% of his cases InFuse had caused postoperative radiculitis or fluid collection, sometimes necessitating additional procedures for the patient. Before trial, defendant moved to limit plaintiff’s expert’s trial testimony to only those risks that actually materialized in this case. The trial court granted this motion, and thus plaintiff’s expert was only allowed to testify about the risks of ectopic bone growth and inflammatory reactions at trial.
The jury eventually returned a verdict for defendant, and plaintiff appealed. On appeal, plaintiff argued that this limitation on his expert’s testimony was improper, but the Court of Appeals affirmed the trial court. Plaintiff then appealed to the Supreme Court which reversed, holding that the exclusion of testimony regarding all the risks was erroneous and ordering a new trial.
Defendant asserted that the risks that did not actually occur in this case were irrelevant and potentially prejudicial under the Tennessee Rules of Evidence. The Supreme Court held, though, that “the jury should have been allowed to hear [plaintiff’s expert’s] complete testimony about the risks of InFuse, as this evidence would have been relevant under Tennessee Rule of Evidence 401 in the jury’s assessment of what a prudent person would have decided if properly informed of all the significant risks.” One element of informed consent is whether a reasonable person would have consented to the procedure had the proper information been disclosed, and all risks, both those that eventually occurred and those that did not, weigh into this factual determination. In reaching its holding, the Court stated:
A prudent person needs to be informed of all ‘perils bearing significance’ in order to give informed consent. ‘Perils bearing significance’ necessarily include those perils that caused harm and those that did not. The fact that a risk did not materialize 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.
(internal citations omitted). The Court found that the erroneous limitation on plaintiff’s expert “more probably than not affected the outcome of the trial,” and accordingly held that plaintiff was entitled to a new trial.
This was clearly the correct result in this case. Limiting expert testimony in an informed consent case based on what complications or risks actually ended up occurring makes no sense, as the very allegation in such a case is that appropriate information was not shared with the patient to allow him or her to make an informed decision BEFORE the procedure. At the relevant time, which is before the procedure, a doctor has no way of knowing what risks will or will not materialize, so any categorization on this basis is illogical in an informed consent case. Likewise, a reasonable patient will make a decision based on all risks vs. benefits of the treatment.
The Supreme Court’s hearing of and decision in this case cleared up bad law created by the previous decision from the Court of Appeals and should be helpful to plaintiffs’ attorneys litigating informed consent cases in the future. It will also help ensure that patients get information they need to know before giving consent to medical treatment.