Recognized Complications of Treatment and Informed Consent – An Update

by John Zen Jackson

In a December 18, 2018 posting in this blog, the recent oral argument before the Pennsylvania Supreme Court in the case of Mitchell v. Shikora regarding exclusion of evidence of risks and complications of a surgical procedure was highlighted.  On June 18, 2019, a divided Pennsylvania Supreme Court filed its decision, 2019 WL 2504475, reversing the decision of the intermediate appellate Superior Court[1] which would exclude such evidence and reinstating the judgment entered on the jury verdict in favor of the defendant. The opinion helpfully illustrates how risk information can be presented at trial in support of a defense that the adverse outcome was a known complication of the procedure and not the result of negligence.

            The factual context of the case arose from a laparoscopic hysterectomy performed in 2016.  The operation began with the physician making an incision into the patient’s abdomen.  In the course of proceeding to separate the layers of tissue, the attending obstetrician-gynecologist detected fecal odor and realized the woman’s colon had been cut.  He discontinued the hysterectomy procedure and called for a general surgeon to evaluate the patient and promptly perform an operation to repair the bowel injury.  This was done with an emergency loop ileostomy during which a portion of the patient’s bowel was brought to the surface and connected to an external pouch.  The patient wore the colostomy bag for an unspecified time.

            In the opinion for the court, Justice Todd reiterated fundamental components of medical liability law.  She noted that ordinarily, a physician did not guarantee the result of treatment and that there was no presumption or inference of negligence merely because a medical procedure resulted in an unfortunate or adverse outcome.  “Indeed, 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.”  She emphasized, however, that an action for lack of informed consent as to possible risks and outcomes was distinct from a claim of medical negligence.  The justice emphasized a proposition that is widely accepted and had been adopted in the unanimous prior decision of Brady v. Urbas, 111 A.3d 1155 (Pa. 2015), that admitting evidence that a patient had been informed of certain risks in a pure negligence action could erroneously suggest to the jury that the patient consented to negligent care and could confuse the jury and cause it to stray from assessing the central question of whether the physician’s actions conformed to the applicable standard of care.  Nonetheless, evidence of risks and complications was properly admitted elucidating the standard of care issues.

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.

The court concluded that the testimony of the defense expert went beyond the specific injury and included the conduct of the physician and the circumstances surrounding that conduct to allow an evaluation of whether the defendant had met the standard of care and the reasons why the injury could occur in the absence of negligence.  This testimony provides a fine example of an expert providing the “whys and wherefores” that New Jersey courts have so frequently identified as essential to sustain expert testimony against a charge of being an inadmissible net opinion.[2]  It quoted this testimony at some length:

I think that really the only place in this case where one can find fault is in the initial incision into the abdomen, and during that incision is the one time during the surgery — I think you have seen pictures of how narrow a site you are going down — it is the one time in the surgery when you are making an incision into a space where you can’t really see where you are going.

You know, you are cutting through tissue that occasionally you can see through it, but very often you can’t see through it at all. Everybody is very different. Most of the time, especially going through a little incision, the more fat, the deeper the longer that incision is. That initial incision, I’ve done over 8,000 case[s] and every time I make that incision, I hold my breath[ ] because you never know 100 percent that that is going to be okay. I feel much better once you are inside and seeing, but that initial incision is when you can’t be sure.

The benefit of doing it that way is that the patient will recover faster, have less pain, sort of both the surgeons and patients are happy to take that risk because it is going to benefit them in the long run; but there is going to be those times where that incision is going to cause a problem like in this case.

Half the time that doesn’t work, half the time you just have to make sure you are pulling up the thinnest amount of tissue you possibly can after you make that cut and you are hoping that there isn’t anything on the other side.

I mean there’s always something behind the peritoneum there. There’s not like there is free space. There’s not gas in your abdomen naturally. There’s always bowel, there’s 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.

            It also noted this exchange during cross-examination:

Q. [Mitchell’s Counsel] I see. And, doctor, as far as the literature is concerned — well, strike that. I think you had indicated in your report that the injury that Miss Mitchell sustained was unavoidable. That’s what you said?

A. Correct.

Q. If it was unavoidable it would happen every time, wouldn’t it?

A. No.

Q. Well, I don’t understand if it is unavoidable, wouldn’t it happen every time?

A. Not necessarily. It is unavoidable in the sense that he did everything he could to avoid it, yet it still happened, so, therefore, it was unavoidable.

            In contrast, in her concurring and dissenting opinion, Justice Donohue had a different perception of this evidence: “Informing the jury that a particular injury is one that can occur during the procedure does not make it more or less likely that the injury occurred as a result of the doctor’s negligence, rendering it entirely irrelevant.”  She also emphasized that the plaintiff’s expert had identified “a crucial step” of transvisualization of the abdomen before making the cut that had not been done by the defendant.  While the defense expert acknowledged that there was no evidence that the operating surgeons had transvisualized the peritoneum before making the cut, he denied that this step was required by the standard of care.  Justice Donohue distilled the defense expert’s testimony to the following: if transvisualization is not possible (or simply not done), proceed with caution and hope for the best.  She framed the issue for the jury as whether transvisualization was required by the standard of care or not. “If so, the failure to do so was negligent; if not, it was not. These questions should have been decided exclusively on this evidence of what was expected of the surgeon in this case.”  

            There was another separate opinion in Mitchell with Justice Wechtconcurring in the result but highlighting four areas of concern.  These included an emphasis on the “imperative that judges carefully police the line between evidence of consent and evidence of risks and complications” and the exclusion of any possible use of the informed consent form that had been signed by the patient even if limited to reading the possible complications set forth in it.  He also noted that studies or literature should not be admissible “if they do not distinguish between complications that occurred as a result of negligence and those that resulted from some other cause.”  He agreed with the majority’s conclusion that this objection went to the weight rather than the admissibility of this evidence and that the parties should have the opportunity to challenge the studies in a Frye hearing.[3]    He ended with his opinion commenting on the inclusion in one submission of a report that had labeled Philadelphia as “The City of Unbrotherly Torts” and putting that city and its courts on a list of “Judicial Hellholes.”  In an admonition to those filing amicus brief, he wrote:

While amici, like parties, are free (and indeed duty-bound) to engage in zealous advocacy, it seems imprudent to rely for such advocacy upon unduly caustic or inflammatory materials that insult or cast aspersions upon the judicial system itself, or upon its component parts. Those filing briefs as friends of the court should consider this as they engage in their important work of informing and enriching the perspectives available to appellate jurists as the latter perform their jurisprudential duties.


[1]  In the blog piece, the citation for the intermediate opinion was stated incorrectly.  The correct citation is 161 A.3d 970 (Pa. Super. 2017).

[2]  The “why and wherefore” or “whys and wherefores” epigram can be found repeatedly in published and unpublished opinions.  However, the more expressive catchphrase would be the “why and therefore” for communicating the basis for the expert’s conclusion.

[3]  Pennsylvania has declined to adopt the standards for expert testimony developed in Daubert v. Merrill Dow and adheres to the test promulgated in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923).  Betz v. Pneumo Abex, LLC, 44 A.3d 27, 53 (Pa. 2012).