You are being sued for malpractice. The plaintiff said your treatment was negligent and caused significant injury. There is no claim for lack of informed consent. At trial, your defense attorney wants to present evidence that informed consent was given for the procedure and the known risks of the procedure. Obviously, the plaintiff objects and wants the court to preclude the admission of any such evidence because informed consent is not on the menu, only the claim for negligence. Can the information be entered into evidence and considered by the jury? Such is the making of Mitchell v Shikora , No. 55 WAP 2017 (Pa. Sup. Ct., June 18, 2019).

In Mitchell v Shikora , the plaintiff required a laparoscopic hysterectomy. The defendant perforated the bowel during the procedure. The plaintiff required emergency reparative surgery, needed an ileostomy bag for a period of time, after which she ultimately recovered. At trial, the plaintiff motioned to exclude evidence of her informed consent and the introduction of the general risks and complications of undergoing the procedure, claiming that introducing such evidence was irrelevant, unfairly prejudicial and that in the end, it would confuse the jury.

The court granted the motion in part by precluding the evidence of the patient having granted informed consent, but it allowed the introduction of the known risks or complications relating to the procedure as they might relate to defining what the standard of care might be. Naturally, the expert witnesses for each side were on opposite sides of the fence regarding whether the defendant met the standard of care; the plaintiff’s experts opined that cutting the colon without properly identifying the anatomy breached the standard of care, whereas the defendant’s experts posited that entering the abdominal cavity laparoscopically is essentially a blind procedure, you can’t see what lays beyond the peritoneum, and that complication can occur even in the absence of surgical negligence. The jury returned a defense verdict.

The appellate court reversed the decision and remanded the case for a new trial on the basis of the following rationale:

Here, while evidence of risks and complications of a surgical procedure may be admissible to establish the relevant standard of care, in this case, such evidence was irrelevant in determining whether [Defendant]… acted within the applicable standard of care…. The fact that one of the risks and complications of the laparoscopic hysterectomy, i.e., the perforation of the bowel, was the injury suffered by [plaintiff] does not make it more or less probable that [the defendant] conformed to the proper standard of care for a laparoscopic hysterectomy and was negligent… .

Moreover, the evidence would tend to mislead and/or confuse the jury by leading it to believe that [Plaintiff’s] injuries were simply the result of the ∖risks and complications of the surgery .

On appeal, the supreme court determined that “…given that complications may arise even when proper care is provided, evidence of risks and complications must be presented to the jury to allow for a complete picture of the applicable standard of care.” The court noted the defendant’s argument by stating,

…a physician is neither a warrantor of a cure, nor a guarantor of a result. Thus, [Defendant’s] offer that evidence of risks or complications addresses not only whether a physician’s conduct fell below the standard of care and caused injury, but is relevant to dispel a finding of negligence with respect to an injury which may have occurred despite the exercise of reasonable care. [Defendant’s] urge that prohibiting such explanatory evidence would prevent a physician from presenting alternative causes, and, in effect, transform physicians into guarantors of a cure .

The plaintiff argued that any evidence about complications is not probative of whether the standard of care was met or not, and thus it should have been excluded because the jury could conclude that because a known risk exists, that fact masks whether negligence was committed or not. The court responded with a primer on evidence. Citing Pennsylvania’s Rules of Evidence, Sections 401-403, the court noted:

Generally, relevant evidence is admissible and irrelevant evidence is inadmissible. Evidence is relevant if it has “any tendency to make a fact [of consequence] more or less probable than it would be without the evidence.” The threshold for relevance is low given the liberal “any tendency” prerequisite. Relevant evidence “is admissible, except as otherwise provided by law.” One such exception is that relevant evidence may be excluded “if its probative value is outweighed by a danger of one or more of the following: unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.” (Emphasis added by the court.)

The court noted that in a malpractice case, the plaintiff is required to prove, through expert witness testimony, that a defined standard of care existed, that the defendant breached that standard of care and that the plaintiff suffered an injury as a direct result of said breach. Therefore, the court stated that knowledge of the risks and complications associated with performing any particular procedure would help determine whether or not a breach of the standard of care occurred. In finding for the defendants, overruling the appellate court, and reinstating the trial court’s verdict, the supreme court essentially closed its determination by stating,

The complex nature of the practice of medicine—requiring, in the litigation realm, expert testimony for virtually all aspects of a plaintiff’s burden to prove negligence, as well as in defense to those allegations—is central to our admissibility inquiry. Determining what constitutes the standard of care is complicated, involving considerations of anatomy and medical procedures, and attention to a procedure’s risks and benefits. Further, a range of conduct may fall within the standard of care. While evidence that a specific injury is a known risk or complication does not definitively establish or disprove negligence, it is axiomatic that complications may arise even in the absence of negligence. We emphasize that “[t]he art of healing frequently calls for a balancing of risks and dangers to a patient. Consequently, if injury results from the course adopted, where no negligence or fault is present, liability should not be imposed upon the institution or agency actually seeking to assist the patient.”

As a result, risks and complications evidence may clarify the applicable standard of care, and may be essential to provide, in this area, a complete picture of that standard, as well as whether such standard was breached. Stated another way, risks and complications evidence may assist the jury in determining whether the harm suffered was more or less likely to be the result of negligence. Therefore, it may aid the jury in determining both the standard of care and whether the physician’s conduct deviated from the standard of care. As such, we hold that evidence of the risks and complications of a procedure may be admissible in a medical negligence case for these purposes .

We find that, without the admission of testimony of known risks or complications, where appropriate, a jury may be deprived of information that a certain injury can occur absent negligence, and, thus, would be encouraged to infer that a physician is a guarantor of a particular outcome. While we recognize that this determination allows for the potential that a jury might mistakenly conclude that an injury was merely a risk or complication of a surgery, rather than as a result of negligence, we believe that the significant consequences of a prohibition on such evidence tip the scales in favor of admissibility; moreover, we are confident that trial judges will serve their evidentiary gate-keeping function in this regard and, through instruction and comment, ensure that juries understand the proper role of such evidence at trial.