Chief Justice SAYLOR.
In this appeal by allowance involving alleged medical negligence, we consider whether a doctor may introduce evidence that the patient was informed of and acknowledged various risks of surgery, although the complaint does not assert a cause of action based on a lack of informed consent.
Appellee, Maria Brady, had a lengthy history of foot problems. By 2007, both of her feet were in pain due to toe deformities. Appellee's podiatrist, William Urbas, D.P.M., successfully treated toes on her left foot with surgery; he then turned his attention to her right foot. Regarding that foot, one of Appellee's primary complaints pertained to a hammer-toe condition of her second toe (next to the big toe). This deformity caused the middle of Appellee's second toe to rise above the plane of the foot, which in turn caused rubbing and pain when Appellee wore shoes.
To address this condition, Dr. Urbas performed a total of four operations between March 2008 and January 2010. Before each surgery, he explained the risks and complications that could occur, and Appellee signed a consent form acknowledging her awareness of these possible outcomes. The first surgery entailed removing approximately one centimeter of bone from the proximal phalanx of the second toe in an effort to straighten the toe. The parties agree that Dr. Urbas was not negligent as to that surgery. Unfortunately, however, this first operation did not finally alleviate Appellee's condition because, in the post-operative timeframe, certain internal tissues contracted, pulling the toe upward once again. Dr. Urbas eventually performed three more surgeries, each involving, among other things, the removal of additional bone material with the expectation that the foot would, over time, generate soft tissue to fill the gap and provide flexibility. Nevertheless, Appellee's pain persisted and, in the end, her toe was less stable and significantly shorter than it had been initially.
In August 2010, Appellee consulted a different podiatrist, Dr. Harold Schoenhaus, who performed a bone-graft operation which returned the toe to approximately ninety percent of its original length. This procedure also had the effect of restoring some of the toe's stability and substantially reducing the pain. Appellee
In December 2010, Appellee filed a complaint against Dr. Urbas, alleging that he negligently treated her toe in the three follow-up surgeries performed after March 2008. She averred that she could not have reasonably discovered the harm she suffered until after the fourth surgery because "Dr. Urbas' advice, assurances and recommendations ... lulled [her] into a false sense of security and concealed the true nature of [her] condition[.]" Complaint at ¶ 18. As to the alleged negligence, Appellee asserted, inter alia, that Dr. Urbas failed to determine the cause of her original toe condition, and recommended and performed procedures that were counter-indicated. See id. at ¶ 22.
Appellee filed a motion in limine to exclude any consent-related evidence at trial, including the surgical consent forms she signed before each procedure. Appellee argued that such evidence was not relevant to whether Dr. Urbas performed within the appropriate standard of care. Further, she maintained that the probative value of this evidence was outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury. Dr. Urbas responded that the risks and complications of surgery would be relevant to Appellee's credibility as a witness and to her state of mind at the time of the surgeries, and that the evidence of consent would not be used to prove or disprove informed consent. The trial court denied the motion and permitted admission of the consent-related evidence.
At the jury trial, experts for both sides testified that the complications Appellee experienced after the first surgery were common, although they differed as to whether Dr. Urbas was negligent in his recommendations, care, and treatment of Appellee. Dr. Urbas testified that he informed Appellee of the possible complications from the surgery and that the follow-up procedures were reasonable to alleviate these problems. At various other points during the trial, Appellee's consent to surgery and her knowledge of the risks involved were discussed.
During deliberations, the jury asked to review the consent forms, stating that they needed to know "what [Appellee] agreed to." N.T., Nov. 9, 2012, at 251. The court provided the forms. Shortly thereafter, the jury returned a defense verdict, specifically finding that Dr. Urbas was not negligent in his care and treatment of Appellee. In light of this finding, the jury did not reach the issues of causation or damages. See Dkt. No. 34 (completed verdict form); see also N.T., Nov. 9, 2012, at 233-35 (reflecting the trial court's explanation of the verdict form); id. at 253 (reflecting the jury's finding that Dr. Urbas was not negligent).
After unsuccessfully moving for a new trial on the basis that the trial court erred in admitting the consent evidence, Appellee lodged a timely appeal. In its Rule 1925(a) opinion, see Pa.R.A.P. 1925(a), the trial court expressed that "[t]he risks and complications associated with the alleged
Id.
In a published opinion, the Superior Court vacated and remanded for a new trial. See Brady v. Urbas, 80 A.3d 480 (Pa.Super.2013). In concluding that the trial court had abused its discretion, the intermediate court adopted the reasoning of the Supreme Court of Virginia regarding the relevancy of consent evidence in a medical malpractice case. In particular, the Virginia court stated:
Wright v. Kaye, 267 Va. 510, 593 S.E.2d 307, 317 (2004), quoted in Brady, 80 A.3d at 484 (ellipsis added).
The court further explained that Appellee's consent to the procedures and her knowledge of the risks did not make the existence of any fact of consequence more or less probable. See Pa.R.E. 401. Thus, the Superior Court established a per se rule of exclusion mirroring that of the Virginia court, explaining that "evidence of informed consent is irrelevant in a medical malpractice case." Brady, 80 A.3d at 484. The court added, in the alternative, that even if such proofs had some marginal relevance in the present case, they "could have misled or confused the jury by leading it to believe that [Appellee's] injuries simply were a risk of the surgeries and that she accepted such risks, regardless of whether Dr. Urbas' negligence caused the risks to occur." Id. Finally, the intermediate court reasoned that the trial court's error was prejudicial, since the consent evidence constituted a central component of Dr. Urbas' defense and the jury reviewed the consent forms during deliberations. See id. at 484-85. Accordingly, the court remanded for a new trial.
We allowed further review on a limited basis primarily to address whether the Superior Court's bright-line exclusionary rule should be sustained. See Brady v. Urbas, ___ Pa. ___, 96 A.3d 988 (2014).
Dr. Urbas argues that consent-related communications between himself and Appellee regarding the purpose, nature, and risks of surgery were relevant in that they helped establish the applicable standard of care. Relatedly, he proffers that his testimony regarding his views prior to the surgery as to possible outcomes and complications lent credence to his position at trial that he met the standard of care, as
Additionally, Dr. Urbas criticizes the Superior Court's use of a per se rule, reasoning that this deviates from the abuse-of-discretion standard applicable to a trial court's evidentiary rulings. As applied here, Dr. Urbas claims that the intermediate court failed to afford sufficient deference to the trial court's reasonable explanation as to why it viewed the informed-consent evidence as relevant. He maintains that the Superior Court also failed to engage in an appropriate balancing analysis under evidentiary rule 403, essentially concluding that any risk of unfair prejudice automatically outweighs probative value.
Appellee responds that the Superior Court appropriately recognized the lack of relevance and prejudicial nature of informed consent evidence in a negligence case, and that its reasoning is consistent with that of courts in other jurisdictions. See Brief for Appellee at 19-22 (summarizing cases). She maintains that consent evidence only serves to confuse jurors because they might conclude that consent to the surgery was consent to the injury. Appellee posits that the jurors in the present trial appear to have labored under this misconception, as they clarified that their purpose in requesting the consent sheets during deliberation was to see what Appellee had agreed to. As well, Appellee reasons that, where, as here, the form contains an extensive list of risks and complications, allowing the jury to consider it presents an unduly high obstacle to recovery for medical negligence. Appellee finally takes issue with Dr. Urbas' argument that the Superior Court failed to apply the proper standard of review or evidentiary balancing test. She indicates that the record reflects that Dr. Urbas used the consent forms and related testimony, not as evidence of adherence to the standard of care or lack of causation, but to show that Appellee understood and accepted the risk of her injuries — thereby demonstrating that the trial court abused its discretion in permitting the introduction of such proofs.
The Pennsylvania Association for Justice, as amicus curiae favoring affirmance, adds that: (a) Appellee's state of mind in consenting to risks is immaterial to the issue of whether Dr. Urbas' treatment conformed to the proper standard of care; (b) such standard should be established via testimony by an expert familiar with current practices in the defendant's area of specialization; and (c) the establishment of a general precept of evidentiary exclusion is not necessarily improper, as some types of evidence are so prejudicial or confusing that they should never be admitted.
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." Pa.R.E. 401. Irrelevant evidence is inadmissible, and relevant evidence "is admissible except as otherwise provided by law." Pa.R.E. 402. The "except as otherwise provided by law" qualifier includes the principle 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." Pa.R.E. 403.
This appeal involves review of an evidentiary decision made by the trial court in light of the above rules. Such decisions are reviewed for an abuse of discretion. See Commonwealth v. Wright, 621 Pa. 446, 472, 78 A.3d 1070, 1086 (2013). An abuse of discretion occurs where the trial court "reaches a conclusion that overrides or misapplies the law, or where the judgment exercised is manifestly unreasonable, or is the result of partiality, prejudice, bias, or ill will." Id. at 462, 78 A.3d at 1080. To the degree the issue of whether the law has been misapplied involves a purely legal question, it is reviewed de novo. See Hoy v. Angelone, 554 Pa. 134, 144, 720 A.2d 745, 750 (1998) (noting that this Court is the final arbiter of state law); cf. In re N.C., ___ Pa. ___, ___, 105 A.3d 1199, 1210 (2014) (observing that, although the standard of review for evidentiary rulings is abuse-of-discretion, whether the admission of evidence violates the Confrontation Clause is a question of law and, as such, is reviewed de novo).
To prevail on a claim of medical negligence, the plaintiff must prove that the defendant's treatment fell below the appropriate standard of care. See Scampone v. Highland Park Care Ctr., 618 Pa. 363, 387, 57 A.3d 582, 596 (2012); see also Toogood v. Rogal, 573 Pa. 245, 254, 824 A.2d 1140, 1145 (2003) (plurality opinion) ("[M]edical malpractice can be broadly defined as the unwarranted departure from generally accepted standards of medical practice resulting in injury to a patient[.]"). We therefore consider whether informed-consent evidence is probative of that question. In undertaking this inquiry, it is important to recognize that such information is multifaceted: it reflects the doctor's awareness of possible complications, the fact that the doctor discussed them with the patient, and the patient's decision to go forward with treatment notwithstanding the risks.
Some of this information may be relevant to the question of negligence if, for example, the standard of care requires that the doctor discuss certain risks with the patient. See, e.g., Viera v. Cohen, 283 Conn. 412, 927 A.2d 843, 868-69 (2007) (finding that a trial court reasonably admitted evidence of informed consent where the applicable standard of care obligated the doctor to discuss particular risks). Evidence about the risks of surgical procedures, in the form of either testimony or a list of such risks as they appear on an
Still, the fact that a patient may have agreed to a procedure in light of the known risks does not make it more or less probable that the physician was negligent in either considering the patient an appropriate candidate for the operation or in performing it in the post-consent timeframe. Put differently, there is no assumption-of-the-risk defense available to a defendant physician which would vitiate his duty to provide treatment according to the ordinary standard of care. The patient's actual, affirmative consent, therefore, is irrelevant to the question of negligence. Accord Warren v. Imperia, 252 Or.App. 272, 287 P.3d 1128, 1132 (2012) ("Evidence of plaintiff's awareness of [information about the nature of the procedure, its inherent risks, or available alternatives] would neither have assisted plaintiff in proving negligence nor have assisted defendant in showing that he was not negligent."); Wright, 593 S.E.2d at 317 (same); Baird v. Owczarek, 93 A.3d 1222, 1232 (Del.2014) (expressing that "assumption of risk is not a valid defense to a medical negligence action"). Moreover, and as the trial court observed, assent to treatment does not amount to consent to negligence, regardless of the enumerated risks and complications of which the patient was made aware. See Brady, No. 10-15584, slip op. at 6; accord Hayes, 927 A.2d at 889 (quoting Wright, 593 S.E.2d at 317); Patten v. Gayle, 69 So.3d 1180, 1187 (La.Ct.App.2011); Gross v. Robinson, 203 Mo.App. 118, 218 S.W. 924, 926-27 (1920).
Nor are we convinced by Dr. Urbas' argument he needed to use evidence of Appellee's affirmative consent to rebut her allegation of having been "lulled into a false sense of security." When viewed in context, this allegation was included in the complaint to support its timeliness under the discovery rule, see generally Crouse v. Cyclops Industries, 560 Pa. 394, 404, 745 A.2d 606, 611 (2000) (explaining that the discovery rule tolls the statute of limitations until the plaintiff knows or should know that she has been injured by another party's conduct), and it was not material to the substantive questions on which liability depended.
Evidence of the patient's consent also tends to confuse the issue because, as the Virginia Supreme Court noted, the jury might reason that the patient's consent to the procedure implies consent to the resultant injury, see Wright, 593 S.E.2d at 317, and thereby lose sight of the central question pertaining to whether the defendant's actions conformed to the governing standard of care. Indeed, the present case illustrates the point: the defense questioned Appellee at length about her having signed the consent forms, elicited testimony from Dr. Urbas on the topic, and made references to the fact of Appellee's consent during its summation — all in an effort to rebut the allegation of negligence. See N.T., Nov. 9, 2012, at 204 (reflecting defense counsel's argument to the jury that Dr. Urbas was not negligent because he had listed a particular risk on one of the consent forms and talked to Appellee about it). The jury, for its part, ultimately focused its attention on what Appellee "had agreed to" and, shortly thereafter,
Accordingly, we hold that evidence that a patient affirmatively consented to treatment after being informed of the risks of that treatment is generally irrelevant to a cause of action sounding in medical negligence.
The Superior Court's order vacating the judgment and remanding for a new trial is affirmed.
Former Chief Justice CASTILLE did not participate in the decision of this case.
Justices EAKIN, BAER, TODD and STEVENS join the opinion.
The Storm court expressed that the only exception it could envision would arise where the patient agrees to "an experimental medical procedure where the standards of care have not yet been fully developed or consents to treatment modalities known to be outside of the medical mainstream." Id. at 884 n. 41 (citing Boyle v. Revici, 961 F.2d 1060 (2d Cir.1992), and Schneider v. Revici, 817 F.2d 987 (2d Cir.1987)). Along these lines, Schneider recognized that an assumption-of-the-risk defense may be available in such cases, so long as there is evidence that the plaintiff expressly consented to any particular risks associated with the unconventional or experimental treatment. See Schneider, 817 F.2d at 995-96. While we do not foreclose a similar ruling in the future, the issue is not presently before the Court.
As previously noted, moreover, in Pennsylvania, lack of informed consent is treated as a distinct claim under a battery rubric. See supra note 2. However, in some jurisdictions informed consent is considered to be a negligence concept. Under such a framework, the consent may be relevant in a medical negligence dispute. See, e.g., Downs v. Trias, 306 Conn. 81, 49 A.3d 180, 188 (2012) (expressing that a physician's failure to adhere to the standard of medical care with respect to communicating risks to a patient may be relevant to a negligence claim).