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ALEX ARGoTTE,-M.D.' APPE_:LLANT

ON REVIEW FROM COURT OF APPEALS
V. CASE NO. 20 14~CA-001050-MR
MCCRACKEN CIRCUIT COURT NO. 08~C1-01512

L

JACQULYN G. HARRINGTON 1 APPELLEE

_ ` OPINION OF THE COURT BY JUSTICE VENTERS
HFImING
This appeal arises out of a medical malpractice claim brought in~ the
McCracken Circuit Court by Appellee, Jacqulyn G. Harjrington, alleging that
Appellant, Dr. Alex|Ar`gotte, failed to obtain her informed consent before
undertaking a surgical procedure on her. In Harrin_gton’s opening statement at `
trial, her attorney informed the court and the jury that she would not present
an expert witness because “you can use your own common sense” to determine
if Harrington had been informed of the risks associated with the procedure.
. After concluding that Harrington could not prevail without the opinion of a
testifying expert, the trial court dismissed Harrington’s claim before the first

Witness was called.

The primary issue before us is Whether Harrington’s concession that she
would not present an expert’s testimony justified the`trial court’s entry of a
directed verdict. The Court of Appeals reversed, concluding that the trial court
too hastily dismissed the case since the evidence to be presented at trial may
have established an exception to the general rule requiring expert testimony to
establish a professional standard of care. The Court of Appeals rendered its ~
opinion one month before the publication of our opinion in Sgrgent v. Shaffer,
467 S.W.3d 198 (Ky. 2015], which plumbed the depths of Kentucky’s statutory
standard for informed consent, KRS 304.40-320. On discretionary review, we
affirm the judgment of the Court of Appeals, although we do so on different
grounds based upon our decision in Sargent. Consequently, We remand the

matter to the trial court for further proceedings

I. FACTUAL AND PROCEDURAL BACKGROUND

Dr. Argotte performed two surgical procedures for Harrington: the
placement of an inferior vena cava filter (IVC filter) and a subsequent gastric
bypass surgery. Harrington’s claim pertains only to the placement of the IVC
filter which was done as a necessary antecedent to the gastric bypass surgery

Before implanting the IVC filter, Dr. Argotte obtained a written consent form
signed by Harrington. Pertinent provisions of the form are as follows:
I have been informed of the nature, risk, consequences, and
alternatives of the operation or procedure to be performed._ The
hospital is requesting that l sign this request form stating that I
fully understand the operation or procedure, Which was explained

by my doctor.

Physic`ian Statement Risk: `

Migration of filterl

I have been made fully aware by Dr. Argotte and / or his staff of the

procedure to be performed and I am now aware of the risks

involved.

Harrington testified in a pre-trial deposition that neither Dr. Argotte nor f
his staff explained the consent form to her and that she felt rushed by Dr.
Argotte’s office staff to sign the papers they handed to her. Harrington also
testified that Dr. Argotte advised her that the IVC filter Was necessary to
protect her from the risks associated with a pulmonary embolism (a blood clot)
that might form as a result of the bypass surgery. I-Ie told Harrington he would
not perform the gastric bypass procedure Without having the IVC filter in place.
Harrington testified that Dr. Argotte never personally advised her of any risks
associated With the IVC filter or the process of implanting it. She was, of
course, ostensibly aware from the written form that “migration of filter” was a
risk, but she was not told that the filter could fracture and that fragments of
the filter could break-loose and travel through her veins to affect vital organs.

About two and one-half years after these procedures Were performed,
Harrington suffered severe chest pain. Prompt medical treatment disclosed
that the IVC filter had fractured, allowing fragments of the device to migrate to
her lungs and lodge there. Doctors surgically removed the main component of

the IVC filter but the fragments in her lungs could not be removed. _She

 

1 The form also identified 19 other “risks” but none of th/em are pertinent to this
appeal.

complains of continuing pain and discomfort and fear that fragments may
migrate further resulting in serious harm or death.

In his opening statement at the start of the trial, Harrington’s attorney
explained to the court and the jury that the evidence would show that Dr.
Argotte obtained Harrington’s consent to the procedure without adequately
informing her of the risks associated With the implanting of an IVC filter. .l-Ie
displayed an enlarged photocopy of the signed consent form identifying
“migration of filter” as a risk but revealing nothing about the risk of “fracturing”
or “fragmentation” of the filter. Counsel informed the jury that the evidence
would show that Dr. Argotte never informed Harrington of the risk that the
filter could fracture and break into fragments which could then lodge in her
lungs, despite his knowledge of that possibility, and that future health
problems or death could result from such fragmentation. Counsel also told the
jury that the evidence Would show that Dr. Argotte never informed Harrington
that the IVC filter could eventually be removed to eliminate the risk of harm
from fragmentation. Counsel also acknowledged that Harringtonwould not
have a doctor testifying “about what a doctor should have told her,” stating
that the jurors could use their common sense to decide what a person in
Harrington’s shoes should have been told.

At the close of Harrington’s opening statement, Dr. Argotte moved for a
directed verdict, arguing that without an expert witness, Harrington was
unable to prove a breach of the standard of care regarding informed consent.

After considering arguments, the trial court agreed that Harrington could not

4

prevail at trial. Accordingly, the trial court directed a verdict in favor of Dr.
Argotte and dismissed Harrington’s claim.

The Court of Appeals reversed the dismissal and remanded the matter to
the trial court. The Court of Appeals concluded that the trial court failed to
consider that evidence adduced at\trial Could establish an exception to the
general rule requiring expert testimony in medical cases. We granted
discretionary review to address the granting of a directed verdict at the
conclusion of the opening statement and to further examine whether
Harrington’s lack of informed consent claim could survive without an expert

witness.

II. ANALYSIS
A. Directed verdicts on opening statements

Before addressing the substantive issue relating to informed consent, we
must first address the unusual procedural posture of this case: the granting of
a directed verdict dismissing the plaintiff’s claim immediately after the
plaintiffs opening statement The general standard for granting a directed
verdict is applicable here as it is in any directed verdict situation. “[A] trial
judge cannot enter a directed verdict unless there is a complete absence of
proof on a material issue or if no disputed issues of fact exist upon which
reasonable minds could differ.” Biermann v. Klapheke, 967 S.W.Zd 16,l 18-19
(Ky. 1998]. “The trial court must draw all fair and reasonable inferences from
the evidence in favor of the party opposing the motion.” Commonwealth v.

Sawhill, 660 S.W.2d 3, 5 (Ky. 1983). On appellate review of an order granting a

5

directed verdict, the test is whether “under the evidence as a whole it would not
be clearly unreasonable for a jury to find [for the plaintiff].” Id.

Both parties in this action recognize, and we agree, that a directed
verdict may be granted immediately after an opening statement However, that
summary disposition of a case is proper “only when counsel has made
admissions that are fatal to his client's case.” Baker v. Case Plumbing
Manufacturing Co., 423 S.W.Qd 258, 259 (Ky. 1968) (citing Riley v. Hombuckle,
366 S.W.2d_304, 305 [Ky. 1963]).

[T]he court may take a case from a jury or enter judgment`where it
is clear from an opening statement either that the plaintiff cannot
recover or that the defendant has no defense, as the case may be.
This regards the statement as a judicial admission of the
nonexistence of or inability to prove a cause of action or a defense,
but even in such a case the action of the court should be exercised
cautiously and only where the admission is clear.

Co-De Coal Co. v. Comi_)s, 325 S.W.2d 78, 79 (Ky. 1959].

In general, a directed verdict should not be granted until the
conclusion of the plaintiffs case. . . . Nevertheless, Kentucky
cases recognize the power of a trial court to decide a case upon the
opening statements of counsel where they clearly and definitely
disclose no cause of action or no defense, or admit facts the
existence of which precludes a recovery by their clients. I-Iowever,
the cases admonish that the practice is a dangerous one and the
power should be exercised with caution.

Lambert v. Franklin Real Estate Co., 37 S.W.3d 77 0, 774 (Ky. App. 2000).
Because fatal judicial admissions in opening statements are rare and the
consequences of a directed verdict before hearing the evidence are severe,

prudent trial judges are cautious and normally reluctant to grant such relief.

Although we disagree with the trial judge’s decision to grant a directed verdict
in this case, we commend the caution and careful deliberation he applied to the
issue.

With this affirmation that a directed verdict may be properly granted at
opening statements before the presentation of any evidence, we next consider
whether this directed verdict was properly granted. The dispositive question is
whether the acknowledgement in Harrington’s opening statement that she
would not present an expert witness to prove her claim that Dr. Argotte failed
to obtain her informed consent was a judicial admission of a “complete absence
of proof on a material issue,” Biermann, 967 S.W.2d at 18, and thus fatal to her
case, Baker, 423 S.W.2d at 259.

B. Lack of informed consent and the need for expert testimony

To determine whether Harrington’s admission that she would not present
expert testimony was fatal to her claim, we must examine the nature of her
claim that Dr. Argotte failed to obtain her informed consent to implant the IVC
filter. We begin With a review of what Kentucky law requires a physician to do
in order to obtain the patient’s informed consent.

KRS 304.40-320 establishes the legal standard for the informed consent
that a physician must have before exposing a patient to the risks associated
with a particular medical procedure. As we explained in Sargent, 467 S.W.3d
at 206-207, a physician obtains the patient’s informed consent to perform a
medical procedure when the two elements of the statutory standard are met.

First, pursuant to subsection (l] of KRS 304.40-320:

\
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 o_f medical or dental practice
among members of the profession with similar training and experience

Second, pursuant to subsection (2) of KRS 304.40-320:

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 or dentally
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

The first element of informed consent requires that the actions of the
l defendant physician in obtaining the patient’s consent to be within_the
acceptable standard of practice of the applicable medical specialty. The second
element of informed consent is an objective standard, requiring that the risk
information conveyed to the patient by the health care provider must be such
that it provides, not the specific patient, but “a reasonable individual,” with “a
general understanding of the . . . 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.” As explained in
Sargent:

Subsection (1) covers the means employed by the health care

provider to obtain the patient’s consent The ‘action of the health

care provider’ in obtaining consent must be ‘in accordance With the

accepted standards of [the relevant] medical or dental practice[.]’

KRS 304.40-320(1). Quite differently, Subsection (2) covers the

content of ‘the information provided,’ and it sets forth the objective

standard that ‘a reasonable individual’ must gain from that

information a- ‘general understanding’ of the risks ‘recognized

among health care providers who perform similar treatments[.]’
KRS 304.40-320(2). The two subsections perform very different

8

functions and address two different aspects of ‘informed consent.’
' 467 S.W.3d at 209. f

Significant to our review is our conclusion in Sargent, based upon the
conjunctive use of the word “and” in the statute between the two subsections of
KRS 304.40-320, that to satisfy the statutory standard for obtaining the
patient’s informed consent, the physician must comply with both subsections
Id. at 207 (“Construed in accordance with its plain terms and obvious meaning,
_. it is readily apparent that . . . a medical treatment provider has satisfied the
duty to obtain the patient's consent only if both provisions are met.”).
Consequently, a breach of the statutory standard may be established by
proving that the medical provider failed to meet either one of the two
subsections of KRS 304.40-320.

To show that a physician failed to comply with subsection (1) of the
statute, a plaintiff must show the physician’s actions for obtaining consent fell
outside “the accepted standard of medical or dental practice.” Ordinarily, the
failure to comply with a medical profession standard can only be proven by
expert testimony. We agree that under the circumstances before us that
without expert testimony, Harrington could not show that “the actions of [Dr.
Argotte] in obtaining the consent of thef patient [were not] in accordance with
the accepted standard of medical . . . practice.” KRS 304.40-320(1]. But the
viability of Harrington’s claim does not depend upon showing a violation of KRS
394.40-320(1). Even if Harrington conceded that element to Dr. Argotte, she

could nevertheless prevail on her claim by showing that the information he

9

provided regarding the risk failed to satisfy the second element, KRS 304.40-
320(2). To comply with the statute, the healthcare provider must satisfy both
elements of informed consent,

Proving the failure to comply with subsection (2) of KRS_ 304.40-320
requires an expert opinion only as needed to establish “whether the ‘risks and
hazards’ involved [in the plaintiffs claim] are among those ‘recognized among
other'health care providers who perform similar treatments or procedures.”’
Sargent, 467 S.W.3d at 209.° Otherwise, whether the physician’s notice to the
patient would provide “a reasonable individual” with a “general understanding
of the procedure and . . . [the] substantial risks and hazards inherent in the
proposed treatment” is a question “perfectly suited for application by jurors of
ordinary competence, education, and intellect” without the need for expert
testimony. Id.

Dr. Argotte himself provided the expertise required to show what risks
associated with the IVC filter should be included in the notice to the patient
In a pre-trial deposition which would be available as evidence at trial, Dr.
Argotte testified that the risks associated with an IVC filter included the risk
that it could “fracture and migrate.” Therefore, the only issue remaining was
the factual question of whether the information he provided about those risks,
“migration of filter,” would provide “a reasonable individual” with “a general
understanding” of the risk that the filter could break into fragments which

could then migrate to other bodily organs. That factual question is one that

10

could readily be resolved by reasonable jurors without the assistance of expert
testimony.

Perhaps a physician would understand “migration of filter” to be
synonymous with “fracturing and fragmenting” and, therefore, within the
professional standard of care. \But the obvious function of KRS 304.40-320(2)
is to require physicians to inform patients of the risks associated with their
treatment using terms generally understandable to a “reasonable individual.”
Harrington’s admission that she would not call an expert witness may have
foreclosed her ability to prove that Dr. Argotte failed to comply with subsection
(lj of KRS 304.40-320, but it was not a judicial admission that would defeat
her ability to prove the physician’s failure to comply With KRS 304.40-320[2).

To summarize, Harrington’s admission that she would not call an expert
to testify was not fatal to her claim and thus was not a proper basis for entry of
a directed verdict Even if Dr. Argotte’s actions, with respect to informing
Harrington of the risks she faced, satisfied the professional standard under
subsection (1) of KRS 304.40-320, or Harrington’s lack of expert testimony
made it impossible for her to prove otherwise, reasonable minds could still
differ on whether Dr. Argotte complied with the KRS 304.40-320(2). Since
providing informed consent requires compliance with both statutory elements,
Harrington could make out a prima facie case by negating only one aspect of
the statutory informed consent standard.

Because all parties acknowledged that fracturing and fragmenting of the

iilter, and the subsequent migration of filter fragments, to other parts of the

ll

body, were risks associated with the procedure, the question of fact remaining
was whether the phrase “migration of filter” would provide a reasonable
individual with a general understanding of that risk. No expert is required for
that determination. Consequently, Harrington’s admission that she would not
be presenting an expert witness cannot be regarded as an admission negating
Harrington’s cause of action. The trial court erred in granting the directed
verdict

C. Harrington’s claim that Dr. Argotte failed to inform her that the IVC
filter could be removed

Harrington also asserted at trial that Dr. Argotte breached his duty to
obtain her informed consent because he failed to inform her that the IVC filter
could be removed. This facet of her claim was also dismissed with the_directed
verdict, We find no fault with the dismissal of that claim. The fact that the IVC
filter could be_ removed after her bypass surgery is not “a substantial risk” of
the IVC filter placement and thus is not subject to the duty of giving informed
consent KRS 304.40-320 is not implicated in that issue.

Perhaps proper medical care dictates that Harrington should have been
advised that the filter could be removed; perhaps not. The issue required
medical expertise that Harrington apparently did not have. We conclude that

the dismissal of that claim by the trial court was proper.

III. CONCLUSION

For the foregoing reasons, we affirm the Court of Appeals’ decision to

reverse the judgment of the McCracke_n Circuit Court dismissing Appellee’s

12

claim. This matter is hereby remanded to the McCracken Circuit Court for
further proceedings consistent with this opinion.

All sitting. Cunningham, VanMeter, and Wright, JJ., concur. Keller, J.
concurs in part and dissents in part byseparate opinion in which Minton, C.J.
and Hughes, J. join.

KELLER, J. CONCURRING IN PART AND DISSENTING IN PART: l
respectfully concur in part and dissent in part l concur with the majority’s
well-reasoned conclusion that a directed verdict may be properly granted
following opening. Furthermore, l agree with the majority that the trial court
properly granted a directed verdict on Harrington’s claim that Dr. Argotte failed
to inform her that the IVC filter could be removed However, I dissent as to
. that part of the majority’s opinion which concludes that a directed verdict was
not proper in this case.

The majority states that Harrington did not need an expert to establish
the` standard of care required in this informed consent case. According to the
majority, “whether the physician’s notice to the patient would provide ‘a
reasonable individual’ with a ‘general understanding of the procedure and . . .
[the] Substantial risks and hazards inherent in the proposed treatment’ is a
question ‘perfectly suited for application by jurors of ordinary competence,
education, and intellect’ without the need for expert testimony.” (Citing
Sargent,_ 467 S.W.3d at 209). While that analysis may apply in some cases, I

do not believe it applies in this case. Because I believe the_standard the

13

majority developed in Sargent and applied herein is fact-intensive, I briefly
summarize the pertinent parts of the record below.

As the majority notes, Dr. Argotte performed two surgical procedures on
Harrington; however, the issue on appeal involves only the IVC filter surgery.
Therefore, like the majority, my focus is only on that surgery and the informed
consent, or lack thereof, that Dr. Argotte obtained from Harrington.

In early May 2005, Dr. Argotte surgically placed an IVC filter prior to
performing gastric bypass surgery. Harrington had no apparent problems with
that filter until December 2007, when she began to experience severe chest
pain and sought treatment in the emergency room. X-rays indicated that the
IVC filter had fractured; two pieces of the filter had lodged in Harrington’s
lungs; and one piece had lodged in her “left pulmonary artery take off.” In
order to prevent any further migration, a surgeon removed the remainder of the
filter. However, surgery to remove the pieces that had migrated was deemed
too risky and those pieces remain in place.

.Harrington filed suit against Dr. Argotte and the IVC filter manufacturer.
The parties eventually dismissed the manufacturer by agreed order, and
Harrington proceeded against Dr. Argotte. Harrington asserted that Dr. Argotte
violated the standard of care by failing to obtain adequate informed consent to
perform the surgery and in how he subsequently performed that surgery. As to
consent, it appears from the record that Harrington believes that Dr. Argotte
should have advised her that: he was using a retrievable IVC filter; the IVC

filter could be removed sometime after surgery, although he was not authorized

14

to do so; there was a risk the IVC filter could fracture; and if the filter
fractured, pieces of the filter could migrate. As to the surgery itself; it appears
that Harrington’s primary complaint was that Dr. Argotte did not remove the
IVC filter after he performed the gastric bypass surgery. Although Harrington
ultimately dropped her claim related to the surgery, that claim is intertwined
with her informed consent claim. Therefore, I summarize the testimony
regarding both informed consent and the surgery below.

Dr. Argotte testified in his deposition that he advised Harrington
regarding deep vein thrombosis (DVT) and the filter’s role in helping reduce the
risks associated with DVT. He also testified that he advised Harrington of the
risks associated with implantation of the filter, including the risks of fracture
and migration. l note that, at the time of the surgery, the medical Community
was not aware that this particular retrievable IVC filter had a greater than
average propensity to fracture and migrate, and Dr. Argotte testified that he
advised Harrington that all filters carried those risks It is not clear from Dr.
Argotte’s deposition whether he advised Harrington that the filter was
retrievable; however, it is clear that Dr. Argotte only intended to retrieve the
filter “if indicated,” and Dr.. Argotte apparently saw no such indication.

Dr. Gaar, Dr. Argotte’s expert witness, testified that the retrievable IVC
filter used by Dr. Argotte in 2005 had been approved for use by the FDA, and
those filters were marketed for both temporary and permanent use. According
to Dr. Gaar, at the time of Harrington’s surgery, retrievable filter fragmentation

was rare and the risk was thought to be no greater than the risk associated

15

with permanent filters2 Despite the rarity of fracturing, Dr. Gaar stated that
he would have advised Harrington of that risk as part of “global informed
consent.”

Regarding the surgery, Dr. Gaar stated that he does not personally
implant IVC filters, leaving that task to interventional radiologists However, he
does require implantation of permanent filters with “super obese” patients in
part because he believes the risk of DVT essentially never completely subsides
post-surgery. Dr. Gaar has never recommended that an IVC filter be removed
and, he noted that, in 2005, most interventional radiologists in his area would
not have attempted to remove a functioning retrievable IVC filter that had been
in place for more than six weeks Finally, Dr. Gaar testified that he believes a
surgeon who implants a retrievable IVC filter with the idea of removing it
should discuss that option with the patient

lI)r. Silverman, Harrington’s expert witness, testified that a surgeon
should not use a retrievable IVC filter unless the plan is to retrieve it.
According to Dr. Silverman, Dr. Argotte should have retrieved the filter no later
than six months after he performed the gastric bypass surgery. As to whether
a surgeon should advise a patient of the risk of fracture and migration, Dr.
Silverman was somewhat inconsistent

Q: In [Dr. Argotte’s] care for this patient do you have any
criticisms that would relate to his informed consent process?

 

2~Dr. Gaar testified that data available at the time of his deposition showed the
IVC filter used by Dr. Argotte fractures approximately 25% of the time. However, at
the time of Harrington’s surgery, the fracture rate for that IVC filter was believed to be
the same as for other retrievable and permanent filters

16

A: I didn’t See informed consent for the inferior vena cava filter
in relation to personally discussing the incidence of fracture and
migration.

Q: Do you believe that a reasonably competent physician
should discuss the specific risks of fracture and migration with a
patient before placing an inferior vena cava filter?

A: We just said that it’s a known complication, fracture and
migration. lf the surgeon himself or herself is placing the filter,
then it’s incumbent-upon them to actually discuss the risks of that
procedure, which would include fracture and migration, which are
really the main risks of that procedure.

Q: I’m going to show you what l understand to be the consent to
surgery signed by Ms. . . . Harrington for the vena cava filter and
ask if the list of risks is an appropriate list of risks in this case.

A: Everything is on here except for the fracture of the filter.

Q: In May of 2005, was fracture of the filter a known risk?

A: Yes.

Q: Is it your opinion that a physician should tell a patient that
fracture of the filter is a potential risk of this surgery?

A: I think migration is good enough. l don’t think it’s
negligence or a lack of patient responsibility or patient duties to list
fracture. l think migration'takes care of that

Q: And am I correct that migration of the filter is listed on this
form?
A: Yes.

Harrington testified that Dr. Argotte told her that he would not perform

the gastric bypass surgery if she did not have an IVC filter. However, she

stated that he did not tell her that the filter was retrievable or whether he

intended to retrieve it Harrington also testified that Dr. Argotte did not tell her

about the risks of fracture or migration. And, although she admitted to signing

17

the consent form, Harrington testified that the form was presented to her along
with a number of other forms she had to sign and that no one explained the
form’s contents to her.

Approximately three weeks before trial, Harrington’s counsel advised
Argotte’s counsel that Harrington would not be calling any expert witnesses to
testify at trial and that Harrington was only pursuing the informed consent
claim. At a pre-trial conference two and a half weeks before trial\and again the
morning of trial, counsel for Harrington confirmed the preceding The morning
of trial, counsel for Dr. Argotte noted that Harrington was not going to call any
physicians to testify at trial. Based on that lack of medical evidence, counsel
argued that, without some medical testimony, Harrington would not be able to
prove that the IVC filter fractured or that pieces of the filter migrated, thus, she
would not be able to prove her case. Counsel for Harrington noted that Dr.
Argotte had never contested the fact that the filter fractured and that pieces
migrated. Furthermore, counsel noted that he could establish those facts
through Dr. Argotte. The court was somewhat skeptical that Harrington could
prove her case; however, the court indicated that it would address the issue
when, and if, it arose during trial, and the parties proceeded with voir dire.

During his opening statement counsel for Harrington stated that Dr.
Argotte did not tell Harrington that: she had a choice as to whether to have a
filter implanted and to choose the type of filter; he was implanting a retrievable
filter which could be removed; there were different.risks and benefits for

retrievable and permanent filters; he was not authorized to remove the filter;

18

and the filter could fracture. According to counsel, _if Harrington had known
the preceding she would have made different decisions Finally, counsel stated
that Harrington would not be calling an expert witness to testify regarding
informed consent because “[y]ou can use your own common sense and decide
for yourself what a person in [Harrington’s] shoes should have been told, and
you can decide whether she was told or not.”

Following this opening statement, Dr. Argotte moved for a directed
verdict In support of his motion, Dr. Argotte argued that Harrington needed
an expert witness to define what the standard of care is Harrington argued
that she did not need an expert relying on language from Keel v.. St. Elr'zabeth
Med. Ctr., 842 S.W.2d 860, 362 (Ky. 1992), “that expert evidence _is not

required in all instances where the claim is lack of informed consent.” The
court recognized the holding in Keel; however, the court noted that the hospital
in Keel “offered Keel no information whatsoever concerning any possible
hazards of this particular procedure[.]” Id. (emphasis in original.) Unlike the
plaintiff in Keel, Harrington admitted that she had been given some
information, and she signed a consent form. Therefore, the court found that
Harrington’s reading and application of Keel was incorrect The court then
granted Dr. Argotte’s motion because the court believed expert witness
testimony was necessary and Harrington had admitted she was not going to
present any such testimony.

Harrington filed a motion to alter, amend, or vacate, which the trial court

denied, and this appeal followed. The Court of Appeals reversed, holding that

19

whether an expert witness is required is fact-specific and the court could not
have made that determination following opening statement because no facts
had been' presented to the jury.

ANALYSIS.

As the majority states, in analyzing a trial court’s directed verdict on
appeal, the “test is whether ‘under the evidence as a whole it would not be
clearly unreasonable for a jury to find [for the plaintiff|.”’ Citing Sawmill, 660
S.W.2d at 5. In making that analysis the Court should view the evidence in
the light most favorable to the party opposing the motion. Biermann, 967
S.W.2d at 18-19.

Initially, I note that Harrington did not argue at trial that she failed to
understand Dr. Argotte’s explanation of the IVC filter surgery and its risks
She argued that Dr. Argotte gave no explanation whatsoever regarding the
surgery, The majority holds that the issue is not whether Harrington was
informed of the risks but whether a reasonable person would have understood
the risk information that was provided. I fail to see how a reasonable person
could have understood, or misunderstood for that matter, an explanation that
she never received. If we take Harrington’s argument at face value, then her
reliance on Keel was appropriate because expert testimony is unnecessary
when a patient receives no information regarding the risks of a procedure. 842
S.W.2d at 862.

However, as the trial court noted, we cannot take Harrington’s argument

at face value because she §§ receive information regarding the risks of the IVC

20

filter surgery. In fact, Harrington signed a consent form acknowledging that
the risks on the form had been discussed with her. Therefore, l believe the trial
court correctly determined that Keel was distinguishable and, pursuant to
Sargent, this Court must determine if the explanation Harrington received met
the requirements of KRS 304.40-420.

In making that determination, the majority relies on Sargent and
undertakes a two-step analysis l dissented in Sargent, however, l recognize
that it is currently the law and therefore should be applied to this set of facts l
believe that the majority’s application of Sargent is too simplistic.4 According to
the majority, the first step in the Sargent analysis is to determine if Dr. Argotte
obtained Harrington’s consent “in accordance with the accepted standard of
medical or dental practice among members of the profession with similar
training and experience.” l agree with the majority that Harrington would not
have been able to prove a violation of this standard without the testimony of an
expert witness

However, I disagree with the majority that Harrington could have met the
requirements of the second step without an expert witness As the majority
states, the primary issue is whether a reasonable person would have
understood that the risk of the filter migrating included the risk that the filter
might “break into fragments which could then migrate to other bodily organs.”
The majority believes that issue “could readily be resolved by reasonable jurors l

without the assistance of expert testimony.” lf that were the only facet of this

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issue, l might agree with the majority’s analysis However, I do not believe that
the step-two Sargent analysis is that simple generally or as applied to this case.

KRS 304.40-320(2) provides that informed consent shall be deemed to
have been given if:

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 or dentally

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[.]

l agree that, under Sargent, the jury could have decided without expert
guidance whether a reasonable person could have understood that “migration”
encompassed fracture and migration. However, that is not all KRS 340.40-
320(2) requires lt also requires that the risk must have been a “substantial”
risk that was “inherent in t_he proposed treatment” and that was “recognized
among other health care providers who perform similar treatments or
procedures.” Id. The majority skirts this requirement by stating that “all
parties acknowledged that fracturing and fragmenting of the filter, and the
subsequent migration of filter fragments, were risks associated with the
procedure.”

lt is true that all of the physicians agreed that there is a risk that IVC
filters, either permanent or retrievable, can fracture. However, whether the
risk exists is not the only issue. The risk must also be “substantial.” l do'not

believe that a jury of laypersons, without guidance from providers who perform

similar treatments or procedures i.e., expert witnesses can independently

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determine whether a risk is substantial.3 Thus, Harrington was required to_
present expert testimony to at least establish the substantiality of the risk, and
I cannot fault the circuit court for directing a verdict when Harrington admitted
she had no such expert '

l note that the majority opinion does not address Harrington’S Complaint
that Dr. Argotte failed to advise her that he was using a retrievable IVC filter. l
would hold that resolution of this issue required expert witness testimony for
the same reasons the majority held that expert witness testimony was needed
regarding Dr. Argotte’s alleged failure to advise Harrington that the filter could
be removed.

Finally, although I disagree with the majority and believe the trial court
correctly granted a directed verdict, l would instruct the trial court on remand
to limit the parties to the evidence`and witnesses that they identified in their

pre-trial disclosures Minton, C.J. and Hughes, J. join.

 

3 Obviously, once there has been an appropriate determination regarding the
adequacy of the informed consent, a plaintiff will have to prove causation and the
other elements of the tort

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COUNSEL FOR APPELLANT:

Jonathan Rodgers Oliver

James Allen Sigler

Whitlow, Roberts, l-louston 85 Straub, PLLC
COUNSEL FOR APPELLEE:

Clifton Aaron Boswell
Clifton A. Boswell, PLC

Charles S. Wible _
Charles S. Wible Law`Offices, PSC

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