Court Opinion

ID: 6326394
Source: CourtListenerOpinion
Date Created: 2022-03-24 15:06:02.865056+00
Date Added: 2024-06-11T09:22:12.040486
License: Public Domain

RENDERED: MARCH 24, 2022
                                                           TO BE PUBLISHED

                 Supreme Court of Kentucky
                                 2020-SC-0587-DG

CHARMIN WATSON AND                                                APPELLANTS
STEPHEN WATSON

                      ON REVIEW FROM COURT OF APPEALS
V.                            NO. 2019-CA-1271
                     SCOTT CIRCUIT COURT NO. 14-CI-00771

LANDMARK UROLOGY, P.S.C. AND                                        APPELLEES
AMBERLY KAY WINDISCH, M.D.

               OPINION OF THE COURT BY JUSTICE VANMETER

                                       AFFIRMING

      Prior to performing a medical procedure, a health care provider is

generally required to obtain the patient’s informed consent. In Kentucky, the

requirements for informed consent are established by statute. KRS1 304.40-

320. The issue we resolve in this case is whether the Scott Circuit Court erred,

as subsequently affirmed by the Court of Appeals, in dismissing Charmin

Watson’s action alleging Dr. Amberly Kay Windisch failed to obtain Watson’s

informed consent prior to surgical placement of a mid-urethral sling to address

complaints of stress urinary incontinence. Based on the record, we hold that

      1   Kentucky Revised Statutes.
the trial court did not err and therefore affirm its judgment and the Court of

Appeals’ opinion.

                 I.   FACTS AND PROCEDURAL BACKGROUND.

       In September 2012, Ms. Watson consulted with Dr. Windisch2

complaining of urinary incontinence. After an evaluation over three visits, Dr.

Windisch recommended the placement of a mid-urethral mesh sling. Dr.

Windisch's medical charting reflects that she discussed possible complications

of the sling surgery with Ms. Watson, although it does not specify which

complications were explained. In her November 5, 2012, office note, Dr.

Windisch documented the following interaction:

       Educational materials concerning the proposed surgical procedure
       were supplied to the patient. I explained the options concerning
       the surgery versus other more conservative treatment. I did tell the
       patient about various alternatives and why the Sling Procedure
       was indicated in her particular circumstance. I advised the patient
       about the possible outcome and the possibility of infection post
       operatively [sic]. The patient expressed an understanding with
       regard to possible complications and outcome.

       Neither Ms. Watson nor Dr. Windisch was able to recall the specifics of

their 2012 conversation. During her deposition, Ms. Watson testified that she

could not remember what complications Dr. Windisch discussed with her, if

any:

       Q.    Okay. Tell me what you remember about the surgery that –
             that Dr. Windisch recommended to you?
       A.    What I can remember – what she recommended?

       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
                        II.      STANDARD OF REVIEW.

      The standard for the issuance of summary judgment is whether the

record demonstrates “no genuine issue as to any material fact and that the

moving party is entitled to a judgment as a matter of law.” CR 56.03. In

Steelvest, Inc. v. Scansteel Service Center, Inc., 807 S.W.2d 476, 483 (Ky. 1991),

we reaffirmed that summary judgment “should only be used to terminate

litigation when, as a matter of law, it appears that it would be impossible for

the respondent to produce evidence at the trial warranting a judgment in his

favor and against the movant.” (Internal quotation and citation omitted). To

survive a properly supported summary judgment motion, the opposing party

must have presented at least some affirmative evidence showing that there is a

genuine issue of material fact for trial. Id. at 482.

      In determining whether the trial court erred in granting summary

judgment,

      [W]e must consider whether the trial court correctly found that
      “there is no genuine issue as to any material fact and that the
      moving party is entitled to a judgment as a matter of law.”
      Kentucky Rule of Civil Procedure (“CR”) 56.03; see also Pearson ex
      rel. Trent v. Nat'l Feeding Sys., Inc., 90 S.W.3d 46, 49 (Ky. 2002).
      We review de novo the trial court’s grant or denial of a motion for
      summary judgment. Caniff v. CSX Transp., Inc., 438 S.W.3d 368,
      372 (Ky. 2014) (citation omitted).

Cmty. Fin. Servs. Bank v. Stamper, 586 S.W.3d 737, 741 (Ky. 2019). We review

the record “in a light most favorable to the party opposing the motion for

summary judgment and all doubts are to be resolved in [her] favor.” Steelvest,

807 S.W.2d at 480.

                                         9
                                III.   ANALYSIS.

      The Watsons argue before us, as they did in the Court of Appeals, that

the trial court erred in granting summary judgment because genuine issues of

material fact existed as to whether Dr. Windisch complied with KRS 304.40-

320. This statute sets forth the requirements of a valid informed consent:

      In any action brought for treating, examining, or operating on a
      claimant wherein the claimant's informed consent is an element, the
      claimant's informed consent shall be deemed to have been given
      where:
      (1) The action of the health care provider in obtaining the consent
      of the patient or another person authorized to give consent for the
      patient was in accordance with the accepted standard of medical . .
      . practice among members of the profession with similar training
      and experience; and
      (2)   A reasonable individual, from the information provided by the
      health care provider under the circumstances, would have a general
      understanding of the procedure and medically . . . acceptable
      alternative procedures or treatments and substantial risks and
      hazards inherent in the proposed treatment or procedures which are
      recognized among other health care providers who perform similar
      treatments or procedures[.]

A physician, or any health care provider, satisfies the duty to obtain the

patient’s consent only if both provisions are met. Sargent v. Shaffer, 467

S.W.3d 198, 207 (Ky. 2015). And, as in any medical malpractice claim, the

plaintiff bears the burden of proof. See Vitale v. Henchey, 24 S.W.3d 651, 656

(Ky. 2000) (stating that “as a result of Holton and the Kentucky Informed

Consent Statute, an action for a physician's failure to disclose a risk or hazard

of a proposed treatment or procedure is now undisputedly one of negligence and

brings into question professional standards of care[]”).

                                        10
      A. KRS 304.40-320(1).

      To show that a physician failed to comply with the first subsection of the

statute, a plaintiff must demonstrate that the physician in question failed to

meet the accepted standard of “the applicable medical specialty” when

obtaining informed consent. Argotte v. Harrington, 521 S.W.3d 550, 555 (Ky.

2017), overruled on other grounds by Univ. Med. Ctr. v. Shwab, 628 S.W.3d 112

(Ky. 2021); Sargent, 467 S.W.3d at 209. In Shwab, we reaffirmed that

informed consent is a process, not a document. 628 S.W.3d at 121 (quoting

Kovacs v. Freeman, 957 S.W.2d 251, 254 (Ky. 1997)). We also noted in Shwab

that the “crucial component” under KRS 304.40-320(1) is evidence that a

medical care provider’s actions did not comply “with the accepted standard of

medical . . . practice among members of the profession with similar training

and experience.” 628 S.W.3d at 125.

      In this case, as in Shwab, the Watsons’ medical expert, Dr. Wilson,

provided testimony that Dr. Windisch breached the standard of care in her

post-operative care of Ms. Watson. Admittedly, Dr. Wilson was critical of what

she knew of Dr. Windisch’s informed consent procedure, specifically that Dr.

Wilson should have provided more specificity in her written detail. The entirety

of Dr. Wilson’s testimony concerning informed consent, is the following:

      Q:    Okay. With the understanding that — and we'll talk about
            this in a minute — that you have concerns about
            discussions with the patient about a reduced efficacy for
            situations where there's not urethral hypermobility, I don't
            see anything in your disclosure here you're making an
            opinion that Dr. Windisch deviated by not adequately

                                       11
      informing the patient of the risks of the procedure. Is that
      fair?
A.    You said that you don't see anything in my disclosure where
      she discussed the reduced risk of efficacy with that? I don't
      know the details of her consent process.
Q.    And maybe we can sort of eliminate a line of questioning
      here. You're not going to offer any opinions at trial that Dr.
      Windisch did not adequately inform the patient about the
      risks of the procedure.
A.    No, because I have not seen any information about her
      informed consent process.
Q.    Okay. You reviewed Dr. Windisch's office notes, correct?
A.    Correct.
Q.    You reviewed the hospital record, correct?
A.    Correct.
Q.    You saw the signed informed consent form?
A.    I'm sure that it was included.
Q.    Okay. I just don't want there to be any loose ends, Doctor.
(Exhibit Number 9 was marked for identification)
Q.    Exhibit 9, I'll show you this. And we can get to Dr.
      Windisch's notes in a minute, but in terms of this consent
      form, clearly Ms. Watson was informed that bleeding,
      infection, damage to the urethra and/or bladder and
      incomplete emptying were potential complications of the
      transvaginal urethral sling being performed by Dr. Windisch,
      correct?
A.    Correct.
Q.    All right. And so in terms of Dr. Wilson's perception of the
      case, is this an adequate — is this adequate to satisfy
      informed consent of this patient?
A.    Not for mesh.
Q.    Okay. Let's look at — On November 5th of 2012, Dr.
      Windisch reported that, “Educational materials concerning
      the proposed surgical procedure were supplied to the
      patient: I explained the options concerning surgery versus
      more conservative treatment. I did tell the patient about
      various alternatives and why the sling procedure was
      indicated in her particular circumstance.” I'm sorry.

                                 12
[Opposing counsel].        I'm just giving her the records so that she
     can —
Q.   We're on page . . .
A.   I see it.
Q.   Okay. Based upon this charting by Dr. Windisch in
     conjunction with the signed consent form, that's adequate to
     inform the patient of the risk complication of the procedure
     correct?
A.   No. I mean, she — “I did tell the patient about various
     alternatives.” They’re not specified, but in my deposition —
     or in my disclosures thing there, you know, I commented
     about the lack of urethral hypermobility. So what those
     various alternatives are, she’s not detailed. They could be
     observation. It could be pessary insertion. It could be
     different types of slings. And when someone doesn't have
     urethral hypermobility and, you know, there’s a known
     decreased efficacy with a midurethral sling for those
     patients, another option is an autologous sling or an
     allograft sling. So when she says “various alternatives,” it's
     kind of vague.
Q.   So what I’m hearing you say is you don’t have enough
     information as you sit here today to assess whether – to
     formulate an opinion on whether or not Dr. Windisch
     complied with the standard of care in terms of informed
     consent.
A.   Correct.
Q.   Okay.
A.   And — Well, I'll just leave it at that.
Q.   Okay.
A.   I mean, in regards to what she wrote on the consent
     regarding complications, those are all potential
     complications associated with any type of sling. I think that,
     though, especially in this era that we're in, especially in light
     of all of the mesh complications that we have, it’s important
     to write the complications that are specific to mesh like
     erosion and extrusion and possible need for revision,
     dyspareunia, fistula formation.
Q.   Do you write each of those on your informed consent?
A.   I do.
Q.   Okay.

                                   13
      A.     Well, I write them in my discussion with the patient detailed,
             so like my notes here would have all of that spelled out.
      Q.     All right. And do you maintain — There are a lot of different
             kits obviously, right, TBTO, TBT, various manufacturers?
      A.     Uh-huh.
      Q.     Those manufacturers have materials that are provided to
             urologists who then can send those on to the patient,
             correct?
      A.     Sure.
      Q.     And those materials typically cover those complications and
             untoward events that you just discussed, correct?
      A.     I don't know because I don't use those materials. I discuss
             them. I make sure as the operating physician that I'm giving
             that information to my patient, not relying on some company
             to do it for me.
      Q.     Sure. But my question was, do those materials contain that
             —
      A.     I don't know because I don't use them.
      Q.     You’ve never looked at them?
      A.     No.

      By contrast, as the Watsons concede, Dr. Windisch’s two experts, Dr.

Mickey Karram and Dr. Howard B. Goldman, both testified that Dr. Windisch’s

actions and disclosures complied with the applicable standard of care in

obtaining Ms. Watson’s informed consent. The Watsons, however, argue that

Dr. Wilson’s testimony created a disagreement about the standard of care that

is appropriately decided by a jury.4 We disagree.

      4   The Watsons additionally point to a 2008 FDA Public Health Notification
titled, “Serious Complications Associated with Transvaginal Placement of Surgical
Mesh in Repair of Pelvic Organ prolapse and Stress Urinary Incontinence.” Although
the Watsons’ Appellants’ Brief fails to detail where in the record this document was
produced to the trial court, their Reply Brief supplies more information and states that
Dr. Windisch’s experts were questioned about this document. Significantly, no doctor
opined that the FDA Notice established an applicable standard of care.

                                          14
      Dr. Wilson expressly did not render an opinion of the standard of care

concerning informed consent. She opined as to her, Dr. Wilson’s, practice.

She discounted the use of manufacturer’s literature. We held in Shwab that

“KRS 304.40-320(1) requires more than one physician’s personal opinion

regarding how [she] believes informed consent should work.” 628 S.W.3d at

125. Thus, Dr. Wilson’s testimony simply does not constitute evidence that Dr.

Windisch’s actions for obtaining consent fell outside the accepted standard of

medical practice. See id. at 125-26 (internal quotations and citations omitted).

      B. KRS 304.40-320(2).

      The second subsection of the statute focuses on the patient’s general

understanding and is couched in terms of a reasonable individual. Specifically,

the focus is on that individual’s general understanding of the procedure,

medically acceptable alternative procedures or treatments, and substantial

risks and hazards inherent in the proposed treatment or procedures which “are

recognized among other health care providers who perform similar treatments

or procedures[.]” KRS 304.40-320(2). As we held in Sargent, this subsection

established the objective standard concerning the information that a

reasonable individual must be provided. 467 S.W.3d at 209. In Shwab, we

held that this information must be evaluated from the perspective of “a

reasonable individual,” and not from the subjective understanding or memory

of the particular plaintiff. 628 S.W.3d at 127.

      Our opinion in Shwab is further important because we explicitly held

that KRS 304.40-320(2) required disclosure of “substantial risks and hazards”

                                       15
as testified to by expert witnesses, i.e., providers who perform similar

treatments or procedures. Id. at 129. In doing so, we overruled Sargent and

Argotte to the extent those opinions suggested “that the substantiality of a risk

is a jury question that does not depend on medical evidence.” Id.

      The record discloses that Dr. Windisch employed recognized methods of

informing her patient of the procedure, alternatives and substantial risks. Dr.

Windisch discussed the proposed sling surgery with Ms. Watson during a clinic

visit on November 5, 2012. Ms. Watson verified that the two had a discussion.

Dr. Windisch provided educational pamphlets to Ms. Watson. Again, Ms.

Watson conceded she was given materials to review and that she “probably

read” them. Dr. Windisch’s discussion was memorialized in a

contemporaneous medical chart:

      I explained the options concerning the surgery versus other more
      conservative treatment. I did tell the patient about various
      alternatives and why the Sling Procedure was indicated in her
      particular circumstance. I advised the patient about the possible
      outcome and the possibility of infection post operatively [sic]. The
      patient expressed an understanding with regard to possible
      complications and outcome.

Dr. Windisch utilized a printed informed consent document. The preprinted

portion of the document identified the general risks and hazards associated

with surgery including “infection, blood clots in veins and lungs, hemorrhage,

allergic reactions, cardiac arrest, and even death.” The informed consent

document allowed for surgery specific information to be handwritten. Here, the

form expressly and unambiguously set out that “Dr Windisch was performing a

“transvaginal urethral sling” to treat “stress incontinence” and that the

                                        16
following were risks and hazards of the particular procedure: l) Bleeding[;] 2)

Infection[;] 3) Damage to urethra bladder[;] 4) Incomplete emptying[.]” Ms.

Watson signed the form on November 14, 2012. The signature was witnessed.

Finally, Dr. Windisch gave Ms. Watson the opportunity to ask questions. The

informed consent document also included a certification by Dr. Windisch that

she had fully explained the risks and benefits of the procedure and “answered

fully all of the patient’s questions.” Dr. Windisch signed the certification.

As previously noted, Dr. Wilson was critical of Dr. Windisch’s failure to

document in writing mesh-specific complications, such as

migration/erosion/extrusion. On the other hand, Dr. Windisch’s testimony

was that she, as matter of habit and routine, discusses the possibility of

erosion and migration with her sling patients, and that the educational

materials she provided addressed mesh-specific complications. Again,

informed consent is a process, not a document. Schwab, 628 S.W.3d at 121.

Dr. Wilson did not opine as to the applicable standard of care, only as to her

practice. Further, Dr. Wilson was ill-suited to advise on the content of any

educational materials since, as she testified, she does not use and has never

looked at them. By contrast, Dr. Windisch’s experts, Drs. Karram and

Goldman, testified that Dr. Windisch had appropriately advised Ms. Watson.

      Based on the foregoing, the trial court did not err in granting Dr.

Windisch’s motion for summary judgment on the issue of informed consent.

                                        17
      C.    Adequacy of Notice Pleading—Informed Consent.

      While the foregoing resolves this matter, we address briefly Dr.

Windisch’s argument that Ms. Watson failed to adequately plead failure of

informed consent. Her argument is that following the November 2012 surgery

and the filing of the complaint in 2014, the first notice that lack of informed

consent was an issue arose in the deposition of Dr. Wilson, in October 2018.

In other words, almost six years following the events at issue. The practical

effect of this lapse was that both Ms. Watson and Dr. Windisch were unable to

testify as to the precise conversations they had in November 2012. In addition,

Dr. Windisch was unable to produce the educational materials she provided to

Ms. Watson.

      “Kentucky is a notice pleading jurisdiction, where the central purpose of

pleadings remains notice of claims and defenses.” Russell v. Johnson &

Johnson, Inc., 610 S.W.3d 233, 240 (Ky. 2020) (internal quotation and citation

omitted); CR 8.01 (“[a] pleading which sets forth a claim for relief, whether an

original claim, counterclaim, cross-claim, or third-party claim, shall contain (a)

a short and plain statement of the claim showing that the pleader is entitled to

relief”). In other words, a complaint is merely required to give a defendant fair

notice and identify the claim. Id. at 241 (citing Grand Aerie Fraternal Ord. of

Eagles v. Carneyhan, 169 S.W. 3d 840, 844 (Ky. 2005) and Cincinnati, Newport,

& Covington Transp. Co. v. Fischer, 357 S.W.2d 870, 872 (Ky. 1962)). And as

held in Holton v. Pfingst, 534 S.W.2d 786, 788 (Ky. 1975), a medical

malpractice claim based on lack of informed consent is a negligence claim.

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Significantly, however, the legislature has effectively codified the elements of

informed consent by enacting KRS 304.40-320.

      Here, the facts demonstrate the issue of informed consent was not

specifically pled or mentioned in discovery until six years after institution of the

suit. When informed consent was raised, it occurred during the deposition of

Dr. Wilson, who twice stated she would not be opining on Dr. Windisch’s

conduct as to informed consent. Consequently, Dr. Windisch reasonably

believed the medical negligence alleged only regarded the surgical implanting of

the urethral sling. As the standard for establishing malpractice in a particular

kind of surgery differs from proving informed consent for that surgery, this

case shows that a general claim of medical malpractice without specific

mention of informed consent fails to give adequate notice of the essential

nature of the claim. Because identifying which professional standard the

doctor is alleged to have violated is essential to a medical malpractice claim, we

now hold a medical malpractice claim based upon lack of informed consent

must be specifically pled since a generalized claim of medical malpractice fails

to give fair notice to the defendant that informed consent will be at issue.

      We know as well that although plaintiffs must specifically plead the lack

of informed consent, necessary information regarding that claim may not

always be available immediately. Therefore, trial courts are encouraged to

allow plaintiffs to freely amend their complaints in appropriate situations.

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                                  IV. CONCLUSION.

      Based on the foregoing, the Scott Circuit Court correctly entered its

judgment dismissing the Watsons’ action. We therefore affirm it and the Court

of Appeals.

      All sitting. All concur.

COUNSEL FOR APPELLANTS:

Bruce Clark Batten, II
David Seth Coomer
Stephen M. O’Brien
O’Brien Batten & Kirtley, PLLC

COUNSEL FOR APPELLEES:

Clayton Lee Robinson
Jonathan David Weber
Robinson & Havens, P.S.C.

COUNSEL FOR AMICUS CURIAE,
AMERICAN MEDICAL ASSOCIATION
AND KENTUCKY MEDICAL
ASSOCIATION:

Sarah Cronan Spurlock
Bethany A. Breetz
Stites & Harbison, PLLC

Philip S. Goldberg
Shook Hardy & Bacon, LLP

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