In Mitchell v. Shikora, the Pennsylvania Supreme Court wrestled with the issue as to whether evidence of surgical complications and risks are admissible in a medical malpractice case. Dr. Shikora began a laparoscopic hysterectomy on Ms. Mitchell by making an incision into her abdomen, and when he opened the sheath of the peritoneum, he detected fecal odor. Dr. Shikora realized that Mitchell’s colon had been severely cut; thus, he abandoned the hysterectomy and consulted with a general surgeon, who performed a successful emergency loop ileostomy, repairing the bowel. Ms. Mitchell, however, was required to wear an external ileostomy pouch for a short period.
Ms. Mitchell filed the instant medical negligence action against Dr. Shikora, alleging that Dr. Shikora breached his duty of care by, inter alia, “failing to take reasonable precautions to prevent [Mitchell] from suffering complications, injuries and/or damages in connection with the surgery.” Ms. Mitchell’s theory was that Dr. Shikora’s failure to identify her colon before making an incision into her abdomen constituted a breach of the applicable medical standard of care. Ms. Mitchell did not plead a claim for battery or lack of informed consent.
Prior to trial, Ms. Mitchell filed a motion in limine to exclude evidence of her informed consent regarding the risks of the procedure, which included perforation of the colon, as well as evidence of the risks themselves, as irrelevant, unfairly prejudicial, or confusing. The trial court granted Ms. Mitchell’s motion with respect to evidence of her informed consent regarding the risks of the procedure, as she had not raised such a claim. However, with respect to whether a bowel injury was a known risk or complication of the surgery, the trial court denied the motion to preclude such evidence. The trial court explained that the evidence that the risks of a laparoscopic hysterectomy included perforation of the colon was relevant to establish the standard of care and whether Dr. Shikora breached that standard.
At trial, Ms. Mitchell offered testimony from a medical expert, who explained the anatomy of the abdomen, and testified that the standard of care included identification of the body structure before making an incision. He ultimately opined that cutting into the colon without proper identification of the anatomy below the incision breached the relevant standard of care.
Dr. Shikora testified that injury to the bowel is a recognized complication of surgery and that the riskiest part of the procedure is entry into the abdominal cavity, “[b]ecause it is blind” and the surgeon “can’t see beyond the skin and the layers below it.” Dr. Shikora’s expert testified that Dr. Shikora complied with the standard of care applicable to laparoscopic hysterectomies, corroborated Dr. Shikora’s testimony to the extent that in making the initial incision, a physician often cannot see through the tissue, and, thus, the surgeon does not know what is behind the peritoneum, and that this is when complications may occur, which can be unavoidable and can occur absent surgical negligence. Furthermore, evidence showed that Ms. Mitchell’s colon was in an unanticipated location in the middle of her abdomen, which led to it being cut.
The jury returned a verdict for Dr. Shikora, and Ms. Mitchell filed an appeal to the Pennsylvania Superior Court, which reversed and remanded for a new trial, concluding that the risks and complications evidence was irrelevant to the issue of whether Dr. Shikora’s treatment of Ms. Mitchell met the appropriate standard of care, and remanded the matter for a new trial. Mitchell v. Shikora, 161 A.3d 970 (Pa. Super. 2017). The Pennsylvania Supreme Court granted allocatur to determine whether the Superior Court’s holding directly conflicts with the Supreme Court’s holdings in Brady v. Urbas, 111 A.3d 1155 (Pa. 2015), which permits evidence of general risks and complications in a medical negligence claim.
The Supreme Court acknowledged that a plaintiff in a medical negligence matter is required to present expert testimony regarding the standard of care (duty); the acts of the physician deviated from the standard or care (breach); and that such deviation was the proximate cause of the harm suffered. Thus, the question for the Court was whether risks and complications evidence is probative of any of the above requirements.
The Court cited to Pennsylvania’s Suggested Civil Jury Instructions for the axiom, “The idea that complications may arise through no negligence of a physician is so ingrained in our jurisprudence that it is often included as part of the instructions to the jury. See Pennsylvania Suggested Civil Jury Instruction 14.10, subcommittee note (“In the absence of a special contract, a physician is neither a warrantor of a cure, nor a guarantor of the result of his treatment.”). It then turned its attention to its decision in Brady, where it held that, although evidence of a patient’s informed consent to a procedure is generally irrelevant to the issues of standard of care and breach of duty and may confuse the jury, evidence of the risks of the procedure themselves may be relevant and admissible, distinguishing between the admission of informed-consent evidence ― such as consent forms, or communications between a physician and a patient regarding the purpose, nature, and risks of surgery ― and the admission of evidence of the risks and complications of surgery.
The Supreme Court noted the complex nature of the practice of medicine as being central to its 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. 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.” The Court also reaffirmed that the weighing of this evidence is for the jury, not the court. Such evidence, and, indeed, any evidence, is to be liberally admitted at trial, and is relevant if it has “any tendency to make a fact [of consequence] more or less probable than it would be without the evidence.” Pa.R.E. 401.
In light of the foregoing, the Court determined that the 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, the Court held that evidence of the risks and complications of a procedure may be admissible in a medical negligence case for these purposes.
The Court further explained 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. The Court recognized 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, it believed that the significant consequences of a prohibition on such evidence tip the scales in favor of admissibility. Moreover, the Court stated that it was 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.