Opinion ID: 6326394
Heading Depth: 2
Heading Rank: 1

Heading: What I can remember – what she recommended?

Text: 2Landmark Urology, P.S.C. was the professional entity within which Dr. Windisch practiced. Landmark and Dr. Windisch will be referred to throughout this opinion collectively as “Dr. Windisch.” 2 Q. Uh-huh. A. Is just that we would go in as an outpatient, and she would insert the mesh sling. Q. Did she explain to you how that would help alleviate your problems or – A. Yes. Q. Okay. Did she explain to you the complications of the surgery? A. No. Q. She didn't give you any materials about the surgery at all? A. She might have gave me some pamphlets or something like that, yes. Q. Did you read those pamphlets? A. Well, I – probably, yeah. Q. Probably. Okay. A. Yes. Q. Did those pamphlets discuss any of the complications with the surgery? A. Not that I can recall, no. Q. All right. In terms of the conversation you had with Dr. Windisch about that surgery, do you have any specific recollection of it? A. No, sir. Q. Okay. So Dr. Windisch may have talked with you about the complications. You just don't remember? A. She may have, yes. Q. Okay. All right. Did you get a second opinion on that surgery, or did you feel comfortable with Dr. Windisch? A. I didn't get no second opinion – opinion, no. Q. Did you feel comfortable with Dr. Windisch at that time? A. At that time, yes. Q. Okay. Did you do any additional research other than looking at the pamphlets Dr. Windisch gave you? Did you get on the internet and research mesh procedures or talk with anyone that had the procedure done before, anything? A. No. 3 While Dr. Windisch was unable to recall the specifics of her conversation with Ms. Watson, she described her customary routine for obtaining a patient’s informed consent for a mid-urethral sling surgery: Q. It says you advised the patient about possible outcome and possibility of infection postoperatively. Sitting here today, I'm sure you don't recall the exact discussion that you would have had with Mrs. Watson, do you? A. No. Q. What do you think you would have – seeing that note, what do you believe you would have told her at that time when you were discussing this procedure? A. What I always discuss with my patients is kind of what I had stated earlier about there is always a risk of recurrence of the incontinence though the idea is that it should last for a good duration of time. There's always the risk that there may be difficulty with emptying the bladder or voiding or – or voiding after the procedure, particularly in individuals with a mixed incontinence, which she had. There's always the risk of damage to the urethra or the bladder. There's always a risk in this situation, discussing using mesh, of migration or erosion or extrusion of that material. More than likely I did discuss with her a pubovaginal sling using either her own autologous fascia or cadaveric fascia, and that can also have those risks. Usually, there’s not so much a risk of erosion, but there’s still a risk of migration or recurrence or incomplete emptying, all that sort of thing. Prior to surgery, Ms. Watson signed an Exposure and Informed Consent Form (“Consent Form”). The Consent Form disclosed that Dr. Windisch would be performing a transvaginal urethral sling procedure to treat stress incontinence and that Ms. Watson acknowledged the following particular risks: “1) Bleeding[;] 2) Infection[;] 3) Damage to the urethra/bladder[;] 4) Incomplete emptying[.]” (Emphasis added). 4 On November 14, 2012, Dr. Windisch performed surgery as planned to install the transvaginal retropubic urethral sling. Following the placement of the sling, Dr. Windisch performed an intraoperative cystoscopy to ensure that the integrity of Watson's bladder and urethra had not been compromised. At the time, she observed no evidence of injury to either organ. Several days later, Ms. Watson experienced an episode of urinary retention, a common complication of sling surgery, but reported that she was doing well afterward. Two months later, in January 2013, Ms. Watson advised Dr. Windisch that she was experiencing no change to her incontinence. On January 29, 2013, Dr. Windisch performed a follow-up cystoscopy, which showed Ms. Watson's bladder and urethra to be normal. Ms. Watson subsequently reported some improvement in her symptoms. In March 2013, Dr. Windisch stopped treating Ms. Watson and referred her to another urologist as Dr. Windisch was relocating her practice to North Carolina. In November 2013, Dr. Ballert, another urologist, evaluated Ms. Watson as she had complaints of pain and incontinence, although the symptoms had improved and were not bothersome. Three months later, Dr. Ballert performed a cystoscopy and discovered that an area of the mesh sling installed by Dr. Windisch had eroded into Ms. Watson's urethra and bladder, requiring reconstructive surgery. In March 2014, Ms. Watson underwent a surgical procedure to remove the mesh but thereafter continued to experience problems she claims originated from Dr. Windisch's sling surgery. 5 In November 2014, the Watsons filed suit alleging that Dr. Windisch “failed to exercise the degree of care and skill that would be expected of an ordinarily prudent person or reasonably competent physician or healthcare provider under like or similar circumstances.” The Watsons’ complaint did not explicitly refer to informed consent, inadequate consent, or the statute outlining informed consent, KRS 304.40-320. Mr. Watson also filed a loss of consortium claim following the results of his wife's surgery. The Watsons’ expert witness, urologist Dr. Tracey Wilson, opined that Dr. Windisch violated the standard of care by failing to diagnose the erosion of the sling in January 2013. Dr. Wilson’s CR3 26 expert disclosure did not include any opinions related to informed consent. In her deposition, Dr. Wilson testified that she did not intend to offer an opinion at trial regarding informed consent because she had not seen any information regarding Dr. Windisch's consent process. However, she did testify that she believed Dr. Windisch's written consent form should have contained warnings regarding mesh-specific erosion and extrusion. The trial court scheduled a jury trial for February 2019. At the final pretrial conference, Dr. Windisch moved in limine to exclude reference to inadequate informed consent, arguing that the Watsons had not adequately pled or advanced an informed consent claim during litigation. Dr. Windisch maintained that the Watsons should be precluded from presenting an informed 3 Kentucky Rules of Civil Procedure. 6 consent claim at trial because it was not explicitly alleged in their complaint, was not raised in discovery, and was not a part of their CR 26 expert disclosures. Dr. Windisch also argued that the Watsons could not meet their burden of proof because the executed informed consent expressly detailed ureteral and bladder injury as a known risk, and the Watsons’ only expert witness had already testified that she did not intend to offer an opinion at trial regarding informed consent. The trial court denied the motion in limine, since informed consent was adequately pled as a claim based in negligence. The trial court, however, converted Dr. Windisch's motion in limine regarding informed consent into a motion for partial summary judgment, hearing arguments on the merits of the informed consent claim. The Watsons argued that Dr. Windisch had failed to obtain informed consent by failing to explain to Ms. Watson the specific risk of injury due to erosion or migration of the mesh sling, necessitating reconstructive surgery. The trial court granted summary judgment in favor of Dr. Windisch on the Watsons’ informed consent claim. The trial court concluded that the Watsons’ claim failed as a matter of law, stating: In the case at hand, the consent form warned the Watson[s] generally of blood clots in veins and lungs, hemorrhage, allergic reactions, cardiac arrest, and death as commonly associated with surgical procedures. The consent form then specifically, through handwritten annotation, warned of bleeding, infection, damage to urethra bladder, and incomplete emptying. Watson has alleged the injuries of pain, incontinence, and pain during intercourse. In comparing Watson's injuries with the risks enumerated in the consent form, this court finds that no reasonable jury could find that Watson was not adequately informed of the risks associated with the procedure for purposes of informed consent. 7 Unlike [Sargent v.] Shaffer[, 467 S.W.3d 198 (Ky. 2015)] and [Argotte v.] Harrington[, 521 S.W.3d 550 (Ky. 2017)], there was no range of possibilities left by the consent form for Watson to judge. No party or expert disputes that the consent form conveys its intended instruction. The expert physician retained by Watson has admitted on record that what is written on the consent form are all complications associated with any type of sling. Watson admits to being provided with pamphlets concerning mesh surgery which she does not remember if she read, nor does she remember the conversation she had with Windisch about the surgery or if they talked about the associated complications. The burden is on Watson to show that Windisch failed to obtain her informed consent and there is an issue of material fact that must be reserved for the jury. In the absence of any expert opinion specifically critical of Dr. Windisch regarding informed consent, and with no real testimony regarding the substance of the conversation, we are left to rely on the signed consent form. Without more evidence to rebut the form, this court does not find any issue of material fact concerning informed consent. The court finds that the signed consent form on its face conveys the risks associated with the surgery. Although Watsons’ claim for Dr. Windisch’s alleged breach of the standard of care in performing the surgery and failing to diagnose the erosion was still pending, the Watsons immediately appealed the summary judgment to the Court of Appeals. That Court dismissed that appeal since it was from an interlocutory order. Watson v. Georgetown Cmty. Hosp., 2019-CA-000264-MR (Ky. App. May 8, 2019). Upon remand, the Watsons then voluntarily moved to dismiss all theories of liability, other than the informed consent claim. The trial court entered an order granting that motion and making its summary judgment as to informed consent final and appealable. CR 54.02. The Court of Appeals affirmed the trial court. On the Watsons’ motion, we granted discretionary review. 8