Defense Digest, Vol. 25, No. 3, September 2019

Medical Malpractice Evidence – Risk In/Consent Out

by Kevin E. Osborne, Esq.

Key Points:

  • Known risks and complications of a surgical procedure are admissible in a medical malpractice case to help establish the standard of care and to determine if the defendant breached the standard.
  • When seeking to introduce evidence of a known risk or complication, the defense expert should also offer an explanation as to why the particular injury suffered is a known risk or complication.


In Mitchell v. Shikora, et al., 209 A.3d 307 (Pa. 2019), the Pennsylvania Supreme Court again considered whether evidence of risks and complications of surgery is admissible in a medical malpractice action where the plaintiff’s complaint does not include a claim for lack of informed consent. In this instance, Lanette Mitchell had undergone a laparoscopic hysterectomy performed by Dr. Shikora. In the course of the procedure, Dr. Shikora cut the patient’s colon, which required surgical repair, including an external ileostomy pouch.

The plaintiff’s primary theory of liability was that the defendant was negligent for failing to identify her colon while performing the hysterectomy. On motions in limine, the trial court precluded evidence of the informed consent process between the doctor and patient, but allowed evidence of the risks or complications of the laparoscopic hysterectomy. At trial, the defense offered testimony that a bowel injury is a recognized complication of the surgery. The riskiest part of the procedure is the entry into the abdominal cavity because it is blind, and at times the surgeon cannot see what is immediately behind where the incision is being made through the peritoneum. It is while making this critical incision when unavoidable complications can occur absent surgical negligence. While contending that the surgeon met the standard of care, the defense also offered evidence that the risks of the procedure include perforation of the colon, which may occur in a properly performed laparoscopic hysterectomy. There was a jury verdict for the defendant.

On appeal, the Superior Court determined that the trial court had erred in allowing the evidence of the risks and complications of the procedure, deciding that such evidence was irrelevant, misleading and confusing. In Brady v. Urbas, 111 A.3d, 1155 (Pa. 2015), the Supreme Court had ruled that evidence of general risks and complications is permitted in a medical negligence claim. The Supreme Court granted allocatur to consider whether the Superior Court’s holding in Mitchell conflicted with its ruling in Brady.

There are two types of evidence that are generally at issue here. First is evidence of the informed consent, including the discussion between doctor and patient, and the consent form itself. Such evidence is irrelevant to any query on whether the physician met the standard of care in treating the patient. Absent a claim for lack of informed consent, this evidence is clearly inadmissible.

The second type of evidence at issue are the risks and potential complications of a surgical procedure. Merely stating or listing what those risks and complications are, without discussion of the consent process, challenged evidence in Mitchell.

The Supreme Court noted that determining what constitutes the standard of care in a medical malpractice action is complicated. It involves considerations of anatomy, medical procedures, and attention to the procedure’s risks and benefits. The evidence of the risks and complications of a procedure may help to clarify the applicable standard of care and could be essential to provide a complete picture of that standard, as well as whether the standard was breached. The court reasoned that the evidence of risks and complications may assist the jury in determining whether the injury was more or less likely the result of negligence. The court concluded that the risk and complication evidence was relevant because it might aid the jury in determining both the standard of care and whether the physician’s conduct deviated. Importantly, it noted: “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.” The Supreme Court was cognizant of the fact that admitting the risk and complication evidence did allow 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.” However, the court felt that the trial court could avoid this potential improper application of the evidence by explaining to the jury, through instruction, the proper role of this evidence.

In Mitchell, the defendant’s expert not only testified that a bowel injury was a risk of the laparoscopic hysterectomy but, critically he explained why that was the case.

Q: It is not really that it is blind, it is just at that one stage the surgeon doesn’t know exactly what is behind the peritoneum. Is that a fair statement?

A: That’s exactly correct.

Q: And furthermore, if a structure were to be behind where it is not – in a position where it is not suppose to be, is that when complications can occur unfortunately?

A: Absolutely. Absolutely. I mean there is always something behind the peritoneum there. There is not like there is free space. There is not gas in your abdomen naturally. There is always bowel, there is always something right on the other side of that, whether it is large intestine or small intestine. It is always an incision where there can be injury.

Q: In the best of possible care?

A: Correct.

*Kevin is a shareholder in our Harrisburg, Pennsylvania office. He can be reached at or 717.651.3713.



Defense Digest, Vol. 25, No. 3, September 2019. Defense Digest is prepared by Marshall Dennehey Warner Coleman & Goggin to provide information on recent legal developments of interest to our readers. This publication is not intended to provide legal advice for a specific situation or to create an attorney-client relationship. ATTORNEY ADVERTISING pursuant to New York RPC 7.1. © 2019 Marshall Dennehey Warner Coleman & Goggin. All Rights Reserved. This article may not be reprinted without the express written permission of our firm. For reprints, contact