There Is Risk in Everything, Even Surgery
In most medical malpractice cases, there are central themes essential to the defense of a physician that often recur depending on the nature of the claim. In many surgical cases, the theme often centers on the concept of risk versus benefit. Jurors understand that, as with life in general, there is no surgery that can be accomplished completely free of risk. Yet, surgery can provide life-sustaining or life-altering benefits. When a patient encounters a surgical complication that results in injury or death, the surgeon invariably will offer that the outcome could not have been avoided and was a known complication associated with a medically necessary and indicated procedure. In contrast, plaintiffs will counter that the poor outcome was not a recognized complication of the procedure itself but, instead, the result of a substandard technique. In other words, the patient will contend that he or she suffered because the doctor had “bad hands,” not because of a recognized, accepted risk of the procedure that has come to fruition.
Many times, when an organ is removed, injury to adjacent structures cannot be avoided. For instance, when a prostate gland is removed for cancer, the anatomic position of the organ itself makes it physically impossible, even with a nerve-sparing approach, to avoid the potential for post-operative incontinence or erectile dysfunction. Other surgeries are made difficult due to the obscuring of the operative field by blood, inflammation, trauma, or cancerous growth, such as where a gall bladder is grossly inflamed. Anatomy can also be aberrant, leading to increased opportunity for injury or failure of repair. In these types of surgical cases, it is incumbent upon the operating surgeon and his consulting expert to bring to life in the courtroom through description, visual aids, and images, the core defense theme that the injury simply could not have been avoided, even if the technique and intra-operative decision-making was exemplary.
The defense bar’s efforts to advance this core theme has been often thwarted by plaintiffs who take the position that, where is no claim for informed consent, any evidence of the risks or complications associated with a surgery is simply irrelevant. Many trial courts have prevented a defending surgeon and his or her witnesses from even using the term “risk” during direct or cross-examinations where the underlying claim was one for negligence only, and not informed consent. This has resulted in trials where a contorted dance has had to be performed, where, during examinations, lawyers have had to tip toe around the central theme of the case and disguise it in terms palatable to the presiding judge but less than clear to the panel of jurors.
Those trial courts that sought to prevent defense counsel from referring to risks or complications in a surgical case where there was no informed consent found the support they needed in Mitchell v. Shikora, 161 A.3d 970 (Pa. Super. 2017). There, the Pennsylvania Superior Court endorsed the exclusion of evidence, not only of a patient’s informed consent to a surgical procedure where only negligence was pled, but also determined that evidence of risks and complications was irrelevant to whether the defendant met the applicable standard of care. Fortunately, the Pennsylvania Supreme Court reversed the decision in Mitchell v. Shikora, 209 A.3d 307 (Pa. 2019). The Supreme Court held that, while evidence of a patient’s consent to a procedure may not be admissible where no informed consent case is pled, this does not mean that evidence of risks and complications is not relevant to the issues to be determined by a jury relating to whether a surgeon has met the standard of care.
Leading up to this important ruling, the key case that distinguished between evidence regarding informed consent and evidence regarding the risks and complications of a surgical procedure was Brady v. Urbas, 111 A.3d 1155 (Pa. 2015), where the court concluded that evidence of a patient’s informed consent was generally irrelevant in medical negligence actions unless lack of consent was at issue. However, evidence of the risks themselves was determined to be relevant to establish the applicable standard of care and, in some cases, to establish whether the given physician breached the applicable standard of care.
Following the high court’s decision in Brady, tension developed amongst the lower courts regarding the admissibility of risks and complications evidence. Generally, at least within Western Pennsylvania, defense counsel’s hands were frequently still tied by in limine rulings that precluded witnesses from referencing the risks and complications of a procedure even where both the plaintiff and defense medical witnesses agreed on the subject. The evidentiary issue arose again Mitchell v. Shikora, leading to a more direct pronouncement on the matter.
In Mitchell v. Shikora, the plaintiff had undergone a laparoscopic hysterectomy during which the defendant physician, Evan Shikora, MD, and his resident, Karyn Hansen, MD, had perforated her colon as they entered the abdomen. An emergency loop ileostomy was required to repair the injured bowel. The plaintiff filed a medical negligence action against Dr. Shikora, alleging he breached the standard of care, in part, by failing to take reasonable precautions to prevent the injury she encountered. Prior to trial, the plaintiff filed a motion in limine seeking to exclude: (1) evidence regarding her informed consent as it related to the risks of the laparoscopic hysterectomy, including perforation of the colon; and (2) evidence of the risks themselves. The trial court granted the motion, in part, by preventing the admission of evidence regarding informed consent. However, it denied the part of the motion that sought to preclude evidence of the risks associated with the surgery.
At trial, the plaintiff’s expert testified that Dr. Shikora breached the standard of care because he failed to identify and to anticipate the position of the colon before entering the abdomen. Importantly, unlike in Brady, the plaintiff was not questioned regarding her pre-operation discussions with Dr. Shikora, during which he advised her about the risks and potential complications of her surgery. Dr. Shikora testified at trial that injury to the bowel was a recognized complication of laparoscopic hysterectomy and explained it is accepted that a surgeon enters the body in a blind manner. This was echoed by defense expert, Ascher-Walsh, MD, who emphasized that unavoidable complications of the surgery may occur during the first incision of a laparoscopic hysterectomy, even in the absence of surgical negligence.
Following the return of a defense verdict, the trial court denied the plaintiff’s post-trial motion for a new trial based on the alleged error in admitting evidence of the risks of organ injury in a laparoscopic procedure, and an appeal to the Pennsylvania Superior Court followed. In what amounted to a misinterpretation of Brady, the Superior Court reversed the trial court’s determination and remanded the matter for a new trial. It was the view of the Superior Court that risks and complications evidence was irrelevant to the jury’s determination of whether Dr. Shikora acted within the applicable standard of care. Further, it found that the evidence was also misleading and confusing. While the court acknowledged that it was undisputed that perforation of the bowel was an accepted risk of an indicated surgery, the panel concluded that this evidence did not make it more or less probable that Dr. Shikora conformed to the standard of care.
The Pennsylvania Supreme Court granted allocatur limited to the specific issue of “whether the Superior Court’s holding directly conflicts with this Honorable Court’s holding in Brady…which permits evidence of general risks and complications in a medical negligence claim?” On appeal, consistent with the defense theme that the injury simply could not have been avoided, Dr. Shikora argued, and the court agreed that, because complications may arise even when proper care is provided, evidence of the risks and complications of a particular surgery are required to be presented to a jury to provide a comprehensive explanation of the applicable standard of care. Dr. Shikora further argued that he should be permitted to introduce evidence of an alternative cause of injury, such as routine medical complications. The plaintiff characterized risks and complications evidence as informed consent evidence, which is generally inadmissible in a medical negligence action absent claims of informed consent, essentially equating the two concepts.
In its analysis, the Pennsylvania Supreme Court first noted that to prevail on a claim of medical negligence, a plaintiff must prove that a defendant’s treatment fell below the appropriate standard of care, i.e., that he or she varied from accepted medical practice. The court then assessed whether risks and complications evidence was probative of the applicable duty, alleged breach of that duty, and causation.
As a preliminary matter, the court noted, “[a] physician is neither a warrantor nor a guarantor of the result of his treatment.” The court further set forth that, “there is no presumption or inference of negligence merely because a medical procedure terminated in an unfortunate result which might have occurred despite the exercise of reasonable care.” Such a principal is imbedded in Pennsylvania jurisprudence as the standard jury instructions encompass the idea that complications may arise during the course of a procedure through no negligence of a physician.
This is not to say that, in consenting to undergo a procedure in light of the associated risks and complications, a patient consents to a physician performing the procedure in a manner that is below the standard of care. According to the Pennsylvania Supreme Court, the two concepts are inherently distinguishable. The Supreme Court noted the Superior Court “blurred the distinction” between evidence of a patient’s actual, affirmative consent to the particular surgery and evidence regarding the risks and complications of the given procedure.
The components comprising the standard of care are complicated and require competent expert medical testimony regarding nature of the medical procedures, including the corresponding risks and benefits associated with its performance. Consequently, “risks and complications evidence may clarify the applicable standard of care, and may be essential to provide . . . a complete picture of that standard, as well as whether such standard was breached.” Put differently, the court explained that risks and complications evidence may actually assist the jury in determining whether the plaintiff’s complained of harm was more or less likely the result of negligence.
Following Mitchell, there is now a clear statement regarding the admissibility of risks and complications evidence. Risks and complications evidence related to a surgical procedure “may indeed be admissible in a medical negligence case, even where there is no informed consent claim. Lower courts now have the opportunity to apply this holding in favor of admissibility. See, Andrusis v. Microvention, Inc., 2019 WL 7205985 (Pa. Super. Dec. 26, 2019) (finding that evidence of the potential complications of the medical device was relevant as to whether the plaintiff’s injury was caused by the device’s failure and not of negligence, and the admission of such evidence was not a reversible error)). Given the Supreme Court’s use of “may,” the admissibility of risks/complications evidence will be decided on a case-by-case basis. Defense counsel will need to be prepared to articulate their core theme of risk/benefit and present the evidence establishing the known, accepted risk of a medically indicated procedure. Risks/complications evidence is now relevant to a jury’s determination regarding the first question they are asked to answer—did the physician breach the standard of care for a treating surgeon in his or her performance of the procedure?
*Kristin is a shareholder in our Pittsburgh, Pennsylvania office and can be reached at 412.803.2002 or klpieseski@mdwcg.com. Sharon, an associate in our Pittsburgh office, can be reached at 412.803.1150 or srstritmatter@mdwcg.com.
Defense Digest, Vol. 26, No. 2, June 2020 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. © 2020 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 tamontemuro@mdwcg.com.