Court Opinion

ID: 4878980
Source: CourtListenerOpinion
Date Created: 2021-08-26 15:09:13.769236+00
Date Added: 2024-06-11T08:12:37.523713
License: Public Domain

RENDERED: AUGUST 26, 2021
                                                         TO BE PUBLISHED

               Supreme Court of Kentucky
                               2019-SC-0641-DG

UNIVERSITY MEDICAL CENTER, INC.                                     APPELLANTS
D/B/A JAMES GRAHAM BROWN
CANCER CENTER; CRAIG L.
SILVERMAN, M.D.; ROGER H.
HERZIG, M.D.; AND UNIVERSITY
MEDICAL CENTER, INC. D/B/A
UNIVERSITY OF LOUISVILLE
HOSPITAL

                  ON REVIEW FROM COURT OF APPEALS
V.                        NO. 2018-CA-1188
               JEFFERSON CIRCUIT COURT NO. 10-CI-006202

REAGAN BROOKE SHWAB AND                                              APPELLEES
HUGH MCNEILLY SHWAB, IV

               OPINION OF THE COURT BY JUSTICE HUGHES

                        REVERSING AND REMANDING

      Reagan Brooke Shwab (Brooke) was diagnosed with a kidney disease

which became severe in 2007, necessitating a kidney transplant. Interested in

avoiding the need for lifetime immunosuppressant drugs following the

transplant, Brooke consented to participate in a Phase I clinical trial that had

as its goal participants achieving tolerance of a transplanted kidney and

avoiding a continuing regimen of immunosuppressant drugs. Shortly after

participating in the clinical trial, Brooke developed myelodysplastic syndrome

(MDS), a rare form of blood cancer.
      Brooke and her husband filed suit against the clinical trial’s medical

providers alleging that her consent to the medical treatment involved in the

trial was invalid pursuant to Kentucky Revised Statute (KRS) 304.40-320, the

statute that provides the framework for determining when informed consent

has been properly given in an action involving medical care. After eight years

of discovery, the trial court found that the informed consent in this case

complied with Kentucky statutory authority and federal regulations and

granted summary judgment to the medical defendants. The Court of Appeals

reversed, holding that the Shwabs presented enough evidence to potentially

convince a jury that the medical defendants did not give them enough

information to reasonably understand the clinical trial or the potential risks.

After careful review, we reverse the Court of Appeals and reinstate the trial

court’s judgment.

                     FACTS AND PROCEDURAL HISTORY

      In 1996 Reagan Brooke Shwab was diagnosed with IgA nephropathy, a

kidney disease in which antibodies build up and damage kidney tissues.1 In

2007 the disease became so severe that she began dialysis. Shortly after

beginning dialysis her kidneys began failing and she needed a transplant.

Brooke’s nephrologist, Dr. Sanford Reikes, referred her to Dr. Kadiyala

Ravindra and the organ transplant team at Jewish Hospital in Louisville,

      1 IgA nephropathy (Berger’s disease), MAYO CLINIC (May 17, 2019),
https://www.mayoclinic.org/diseases-conditions/iga-nephropathy/symptoms-
causes/syc-20352268.

                                        2
Kentucky. The transplant team determined that Brooke was a transplant

candidate and her husband, Hugh “Mack” Shwab, was an eligible donor.

      The Shwabs, both college-educated individuals, met with Dr. Ravindra

on January 24, 2008 to discuss the transplant process and her need to take

immunosuppressant drugs after the transplant. They also discussed possible

complications related to the immunosuppressant drugs. During this meeting

the Shwabs asked about a clinical trial involving bone marrow transfusion that

Mack’s mother had heard about on the radio. Dr. Ravindra, the trial’s

principal investigator and transplant specialist, explained the trial and its past

results.

      In 2003 the Institute of Cellular Therapeutics (ICT) and the James

Graham Brown Cancer Center at the University of Louisville partnered with the

Northwestern School of Medicine to conduct a Phase I clinical trial involving

kidney transplants.2 The trial’s ultimate goal was to allow a subject’s body to

develop “tolerance” to the transplanted kidney and thereby avoid the need for

long-term anti-rejection drug therapy. The clinical trial used a combination of

a stem cell transplant and kidney transplantation from the same donor, along

with sequential chemotherapy and total body irradiation.3 The trial began in

      2 The study was called “Induction of Donor Specific Tolerance in Recipients of
Live Donor Kidney Allografts by Donor Stem Cell Infusion” (hereafter referred to as
Phase I clinical trial or clinical trial).
      3 Total body irradiation, as explained in the materials provided to Brooke, is
radiation therapy involving the use of high energy x-rays directed to the entire body.
The purpose of total body irradiation is to kill cancer or abnormal cells and suppress
the immune system before transplantation with healthy bone marrow.

                                           3
2003 and was sponsored by Dr. Suzanne Ildstad, a professor of transplantation

and surgery at the University of Louisville who focused her research on ways to

induce tolerance in transplant patients.

      Clinical trials range from Phases I through IV.4 A Phase I trial is an

initial safety trial on a new medicine or treatment, usually done with a small

group of people to begin identifying unknown side effects.5 Phase I trials are

focused on establishing tolerability, i.e., whether the patient tolerates the

medication or procedure, primarily looking for indices of safety.6 Because a

Phase I clinical trial’s process and procedures are previously untested in

humans, toxicity is unknown, and safety cannot be guaranteed.7

      Several meetings occurred between the Shwabs and various medical

providers regarding the clinical trial. After their initial discussions about the

clinical trial Dr. Ravindra introduced the Shwabs to Elizabeth Reed, the trial’s

clinical nurse manager. Reed spoke with the Shwabs for approximately fifteen

to twenty minutes and explained the nature of a Phase I trial and the trial

protocol.

      The protocol for the trial proceeded as follows: the patient would receive

chemotherapy for three days to suppress the immune system; the following

      4 There are five phases of clinical trials: Early Phase 1 (formerly known as Phase
0), Phase I, Phase II, Phase III and Phase IV. U.S. National Library of Medicine, Learn
About Clinical Studies, https://clinicaltrials.gov/ct2/about-studies/learn (last updated
Mar. 2019).
      5   Id.
      6   Id.
      7   Id.

                                           4
day, the patient would undergo total body irradiation; the day after the

radiation, the patient would receive an infusion of stem cells from the kidney

donor; and one to two months later the patient would receive the kidney

transplant.8 The goal of the trial was to make the participant’s body more

receptive to the donated kidney and negate the need for anti-rejection and

immunosuppressant drugs after the transplant.

      The Food and Drug Administration (FDA), tasked with ensuring the

protection of the rights, safety and welfare of human subjects who participate

in clinical trials, reviewed the clinical trial protocol and consent form. 21

United States Code (U.S.C.) Chapter 9. Because the clinical trial was

regulated, in part, by the FDA, the clinical trial had to satisfy federal

regulations governing the protection of human subjects. 21 Code of Federal

Regulations (C.F.R.) Part 50. The clinical trial was funded in part by the

United States Department of Defense, which also reviewed the protocol and

informed consent form. In addition, the Department of Defense requires the

use of a Data Safety Monitoring Board which consists of a group of

independent scientists who monitor the safety and integrity of a clinical trial.9

      8   Brooke was one of the first participants to undergo this specific protocol. The
trial originally began in 2003 and involved simultaneous conditioning, bone marrow
transplant, and kidney transplant. Over four years approximately twelve participants
underwent the protocol, but it was relatively unsuccessful. Immediately prior to
Brooke’s participation, the protocol was changed to a sequential approach. The trial’s
investigators believed there would be a benefit to doing the conditioning regimen and
bone marrow transplant separately so that participants would have time to recover
and heal prior to receiving the kidney transplant.
      9 U.S. National Library of Medicine, Learn About Clinical Studies,
https://clinicaltrials.gov/ct2/about-studies/learn (last updated Mar. 2019). A Data
Safety Monitoring Board can recommend to the sponsor that a trial be stopped if it is
                                            5
Also, an Institutional Review Board (IRB) reviewed the protocol and consent

form and monitored the clinical trial.

      When the Shwabs met with Elizabeth Reed to discuss the clinical trial

initially, Dr. Ravindra was present for part of the discussion. Dr. Ravindra also

discussed the risks and benefits of the clinical trial. Reed later testified that

she gave the Shwabs the sixteen-page consent form to take home and read, a

form which detailed the trial and possible side effects, including cancer,

infertility and death. She also provided a brochure prepared by Dr. Ildstad

describing the trial. Mack later claimed that the couple was not given the

consent form to take with them. At this point the Shwabs expressed interest in

participating in the trial.

      In their depositions the Shwabs stated that Reed told them that they

could expect virtually no side effects and that the worst-case scenario was that

the trial would not work and Brooke would need a traditional kidney

transplant. Additionally, Brooke testified that no one explained that the

purpose of the trial was to determine whether the protocol was safe and

effective. Mack also testified in his deposition that Reed explained that the

worst that had happened to anyone in the trial was that they had to take more

anti-rejection medication, but that most people who underwent this process

ineffective, is harming participants, or is unlikely to serve its scientific purpose. Dr.
Ildstad testified that the Data Safety Monitoring Board includes highly respected
experts who are completely independent of the study. The Board routinely meets twice
a year to review all subject data and study protocols.

                                           6
achieved tolerance of the donor kidney. Conversely, Dr. Ravindra testified that

as of the date of his conversation with the Shwabs, January 24, 2008, no

participants had achieved tolerance and that he personally gave the Shwabs

that information.

      Brooke had a follow-up appointment with her nephrologist, Dr. Sanford

Reikes, who was treating her for end-stage renal disease. They discussed the

trial and Dr. Reikes described the potential benefits as substantial. He also

informed Brooke that the risk of recurrence of her particular type of kidney

disease in the transplanted organ may not be known. The Shwabs had several

follow-up appointments with Dr. Ravindra in February 2008 primarily focused

on Mack’s candidacy as a kidney donor. The clinical trial was mentioned at

these meetings, and Dr. Ravindra encouraged the Shwabs to meet with all of

the members of the trial before deciding whether to participate.

      On February 26, 2008, the Shwabs met with Dr. Craig Silverman, a

professor of radiation oncology at the University of Louisville. Dr. Silverman’s

only involvement in the clinical trial was administering the total body

irradiation and he did not collaborate with Drs. Ildstad, Ravindra, and Roger

Herzig in developing the protocol or the sixteen-page informed consent form.

Dr. Silverman discussed the purpose of the total body irradiation, the

technique, and the side effects, including potential “second cancers,” such as

blood cancers, leukemia, lymphomas, and bone cancers. Dr. Silverman had a

separate consent form, “Explanation of and Consent to Radiation Therapy,” on

which he handwrote the words “second cancer” during this February 26, 2008

                                        7
discussion. Dr. Silverman also provided two pamphlets that detailed radiation

therapy and total body irradiation, identifying potential side effects, for the

Shwabs’ review. After this meeting Brooke signed the consent form and agreed

to participate in the clinical trial.

      The Shwabs also met with Dr. Herzig, a professor of hematology and

oncology at the University of Louisville and a clinical trial co-investigator, on

March 10, 2008 for an evaluation and discussion of the trial. Dr. Herzig

reviewed the trial’s regimen and potential complications with the Shwabs. Dr.

Herzig indicated that he spent an “extended period of time” with the Shwabs.

He discussed the clinical trial informed consent form, focusing mostly on the

portion of the protocol with which he was involved. Following this meeting,

Brooke signed a revised consent form.10 Excerpts from that consent form

include:

      The purpose of this study is to determine if this procedure is safe
      . . . . (p. 2)

      This is a Phase I research study. Phase I is research in which the
      safety of the procedure is evaluated. . . . However, the approach in
      this study using X-ray therapy and facilitator cells has not been
      done before. This procedure is investigational, which means it has
      not been approved by the U.S. Food and Drug Administration
      (FDA). (p. 2)

      This combined bone marrow procedure is basically untested in
      humans. . . . The safety and effectiveness of this study procedure
      will be evaluated. . . . (p. 2)

       10 The March 10, 2008 consent form is the most recent version. While Brooke

originally consented to participate in the trial on February 26, 2008, the consent form
was amended because the Department of Defense provided funding and free care was
provided to trial participants at government facilities. The initial consent form
provided for care at Jewish Hospital. The February 26, 2008 consent form is not in
the record, but the parties agree the March 10, 2008 consent form is controlling.

                                           8
      ....

      Presently, drugs are required to prevent rejection of a transplanted
      kidney. The drugs used to treat rejection have many side effects.
      Besides weakening your body’s ability to fight infection, they can
      also cause high blood pressure, kidney damage, and possible
      cancer. (p. 4)

      ....

      Each of the different parts of this study may result in increased
      risks of serious complications, including death. (p. 5)

      ....

      There is also a very low risk of developing cancer related to the
      radiation during the course of your lifetime. (p. 5)

      ....

      It is not possible to be informed of every possible complication or
      risk. (p. 6)

      ....

      Other risks: [associated with the use of Mycophenolate mofetil
      (MMF), an immunosuppressant drug] – lymphoma (cancer of the
      lymph nodes) . . . . (p. 7)

      ....

      There may be unknown risks, which are not known at this time.
      (p. 7)

      ....

      These delayed effects may include certain types of cancer. (p. 8)

      The Shwabs allege that Reed verbally told them they could expect

virtually no side effects, that the worst-case scenario was that the clinical trial

would be unsuccessful and that Brooke would have to undergo a traditional

kidney transplant; that the doctors involved in the trial made similar

                                         9
statements or did not discuss the risks at all; and that they were told the

clinical trial had been successful in five other patients, which was not true.

Although Mack testified that they were told the trial had achieved success in

five people,11 Dr. Ildstad testified that at the time Brooke entered the clinical

trial no participants had achieved the study’s goal of avoiding the need for

immunosuppressants.

      Brooke began her treatment in the clinical trial in March 2008 and her

kidney transplant was performed in June 2008. For over a year after the

transplant, Brooke’s white blood cell count remained low and she continued to

feel ill. The clinical trial’s medical providers could not determine what was

wrong, so she travelled to Northwestern University in Chicago to obtain a

second opinion. There she was diagnosed with MDS. One of the doctors at

Northwestern University and Dr. Ravindra indicated that the trial could have

caused the MDS. After seeking treatment for MDS, Brooke learned that her

body had rejected the kidney transplant she received during the clinical trial.

      On September 2, 2010, the Shwabs filed a complaint against Dr.

Ravindra, Dr. Silverman, Dr. Herzig, Dr. Ildstad, the University Medical Center

and the ICT (the medical defendants)12 for negligent failure to adequately

      11  Mack explained that the information about the successes in five people in the
trial were from various trials. Reed testified that, as a clinical research manager for
the ICT, she managed four trials—two kidney trials, one heart trial, and a sickle cell
study at a children’s hospital.
      12 On September 23, 2010, the Shwabs filed a separate action against Jewish
Hospital claiming negligence, lack of informed consent and loss of spousal consortium.
On January 10, 2011 that action was consolidated with the Shwabs’ claim against all
other medical defendants. Jewish Hospital filed a motion for summary judgment on
October 23, 2014 because none of the individuals involved in the clinical trial were
                                          10
inform Brooke of the risks of participating in the clinical trial.13 They claimed

that had they been properly and adequately informed of the risks, then Brooke

would not have given consent.

      The Shwabs named two experts in support of their claims. Dr. Lee

Levitt, a retired board-certified hematologist and oncologist, testified by

deposition that the informed consent for the trial was deficient. Dr. Levitt

opined that the Shwabs did not understand the nature of a Phase I clinical trial

or the potential toxicity of this particular trial. He did not believe that the

alternatives were highlighted to the extent they should have been. He also

opined that the informed consent form should have included more specific

information about the risk of cancer, specifically MDS, and that the informed

consent process made the risks seem relatively modest. Additionally, Dr. Levitt

believed that Brooke should have been informed that there were alternatives,

such as a traditional kidney transplant from her husband in which she had an

agents or employees of Jewish Hospital. While Jewish Hospital was listed as a site for
the clinical trial on the informed consent form, the only procedure performed at
Jewish Hospital was the removal of one of Mack’s kidneys. The Shwabs did not object
to summary judgment and their claims as to Jewish Hospital were dismissed on
March 27, 2014.
      13  The Shwabs named the University Medical Center as a defendant in its
capacity as the James Graham Brown Cancer Center and as the University of
Louisville Hospital. The ICT filed a motion for summary judgment because it is not a
separate legal entity. Rather, the ICT is simply a designated institution within the
University of Louisville itself, approved by the University of Louisville Board of
Trustees. In short, the ICT is part of the University of Louisville. The Shwabs did not
oppose the motion. The trial court dismissed the ICT from the action on April 26,
2012 and Dr. Ildstad, the Director of the ICT, on April 29, 2013. Dr. Ildstad never
met, treated or had any contact with the Shwabs.

                                          11
estimated 85% chance of success, albeit with the necessity of

immunosuppressant drugs.

      The Shwabs also identified another expert, Dr. Guillermo Garcia-Manero,

who treated Brooke for MDS at MD Anderson Cancer Center in Houston. His

testimony focused on the cause of the MDS and he opined that the

chemotherapy and radiation Brooke underwent in conjunction with the bone

marrow transplant were most likely the cause. He spoke extensively about the

difficulty of diagnosing MDS and determining its cause. Dr. Garcia-Manero did

not testify regarding informed consent.

      On April 21, 2017, the remaining medical defendants collectively filed a

motion for summary judgment arguing that the Shwabs failed to prove their

claim of improper informed consent. The defendants asserted that the consent

form Brooke signed sufficiently informed her of all known or reasonably

anticipated risks associated with participation in the clinical trial. The Shwabs

opposed the motion and argued that the adequacy of Brooke’s informed

consent was a jury question.

      On July 10, 2018, the trial court granted summary judgment in favor of

the medical defendants. The trial court concluded that the lengthy consent

form Brooke signed complied with Kentucky statutory authority and federal

regulations. While the form did not explicitly include MDS as a risk, it stated

that participation could result in a risk of “various cancers” and listed a

multitude of risks and side effects. Brooke was given ample opportunity to

review the form and consult with medical providers prior to giving consent.

                                        12
The trial court noted Brooke was the first known individual to have developed

MDS following participation in the clinical trial or similar study and thus MDS

was not a reasonably known risk. Because it found no genuine issues of

material fact regarding her claim that the medical defendants failed to properly

inform her of the reasonably known risks associated with the clinical trial, the

trial court granted summary judgment to the defendants.

      The Court of Appeals reversed the trial court’s opinion and order because

it believed that the Shwabs presented enough evidence to defeat a motion for

summary judgment. The appellate court focused on the deposition testimony

of Dr. Levitt, who opined that the medical defendants used a deficient informed

consent form, a form that should have, but did not, mention certain specific

risks, such as stem cell damage, leukemia and MDS. He also claimed that

MDS is a known side effect when total body irradiation and chemotherapy are

used in conjunction. While the medical defendants presented evidence to the

contrary, the Court of Appeals concluded that conflicting evidence made the

adequacy of the informed consent an issue for the jury. Additionally, that

court noted that the Shwabs testified that no one explained the possibility that

there could be extreme risks associated with the trial and that they were only

told that, at worst, the trial would not work. Ultimately the Court of Appeals

concluded that the Shwabs presented enough evidence to potentially convince

a jury that the medical defendants did not give them enough information to

reasonably understand the trial or the potential risks.

                                       13
      Having granted discretionary review, heard oral arguments and carefully

considered the record, we reverse the Court of Appeals.14 Given the

undisputed facts and applicable law, the trial court properly granted summary

judgment.

                                      ANALYSIS

      On appeal, we review a summary judgment de novo. Shelton v. Ky.

Easter Seals Soc’y, Inc., 413 S.W.3d 901, 905 (Ky. 2013). We must consider

whether the trial court “correctly determined that there were no genuine issues

of material fact and that the moving party was entitled to judgment as a matter

of law.” Fluke Corp. v. LeMaster, 306 S.W.3d 55, 59 (Ky. 2010). To defeat

summary judgment, the Shwabs must have presented affirmative evidence that

a genuine issue of material fact exists. Steelvest, Inc. v. Scansteel Serv. Ctr.,

Inc., 807 S.W.2d 476, 480 (Ky. 1991).

      Turning to the substantive law of informed consent, “it is a well-

established principle of law that, as an aspect of proper medical practice,

physicians have a general duty to disclose to their patients in accordance with

accepted medical standards the risks and benefits of the treatment to be

performed.” Sargent v. Shaffer, 467 S.W.3d 198, 206 (Ky. 2015). KRS 304.40-

320 provides the informed consent standard:

      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:

       14 Dr. Ravindra did not move this Court for discretionary review and is not a

party in this appeal.

                                          14
      (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
      or dental 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 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 . . . .15

(Emphasis added.) Examining the contours of informed consent, this Court

has noted that “[t]he two subsections perform very different functions and

address two different aspects of ‘informed consent.’” Sargent, 467 S.W.3d at

209. A physician must comply with both subsections in order to satisfy the

statutory standard for obtaining informed consent. Id. at 207. Therefore, a

breach of the statutory standard for informed consent can be established by

proving that a medical care provider failed to meet either subsection of KRS

304.40-320. Argotte v. Harrington, 521 S.W.3d 550, 556 (Ky. 2017).

      I. The Actions of the Medical Care Providers Satisfied Subsection
         One of the Informed Consent Statute.

      The requirements of each subsection of KRS 304.40-320 were explained

in Sargent, 467 S.W.3d at 209 (quoting KRS 304.40-320(1)):

      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

      15 KRS 304.40-320(3) provides requirements for obtaining informed consent in

emergency situations; that subsection is inapplicable in this case.

                                        15
      the accepted standards of [the relevant] medical or dental
      practice[.]”

Thus, to meet the requirements of the first subsection the Shwabs must show

that the process by which the medical defendants obtained her consent did not

comply with “accepted standards” within the medical profession.

      As this Court has expressly recognized, informed consent “is a process,

not a document.” Kovacs v. Freeman, 957 S.W.2d 251, 254 (Ky. 1997). Over

the course of several weeks in early 2008 Brooke met with five medical care

providers, four providers associated with the clinical study plus her own

nephrologist, for what the medical defendants estimate was a total of 120

minutes. During these meetings Brooke was informed of the trial’s lack of

success, substantial risks, and potential complications. The Shwabs also had

the opportunity to ask questions and receive answers from the medical

specialists. In addition, during their initial discussions about the clinical trial,

they were given the detailed informed consent form to take home and review.16

Although informed consent is a process, the detailed informed consent

document Brooke signed is highly relevant in our analysis.

             The existence of a signed consent form gives rise to a
             presumption that patients ordinarily read and take whatever
             other measures are necessary to understand the nature,
             terms and general meaning of consent. To hold otherwise
             would negate the legal significance to written consent forms

      16  As noted, Mack disputes that they were allowed to take the consent form
home. Reed testified that she gave it to them because it was required by the protocol
for the clinical trial. Dr. Ravindra also testified that providing a copy of the consent
form was part of Reed’s typical routine when explaining the clinical trial to a
candidate.

                                           16
             signed by the patient and render the consent form
             completely unreliable.

Hoofnel v. Segal, 199 S.W.3d 147, 151 (Ky. 2006).17 Our review of the record

reflects that Brooke had ample opportunity to review the consent form and

ensure that she understood its contents.

             Dr. Ravindra met with the Shwabs on January 24, 2008 to
      discuss Brooke’s candidacy for a kidney transplant. Dr. Ravindra
      described the Shwabs as “very intelligent, very sharp” people. As noted,
      Mack’s mother first brought up the trial, stating that she heard about it
      on the radio. Dr. Ravindra later testified that he explained chimerism,18
      avoiding immunosuppression and that chimerism was not achieved in
      the nine participants who had taken part in the clinical trial. He recalled
      that the Shwabs had concerns about graft versus host disease and he
      explained that it was a serious complication and that their fears were
      genuine. Dr. Ravindra also encouraged the Shwabs to meet with Dr.
      Herzig and Dr. Silverman to help ensure they understood the clinical
      trial prior to deciding on whether to participate. In his second meeting
      with the Shwabs, the Shwabs asked a number of questions about what
      Mack would have to do for the trial. Dr. Ravindra testified that at the
      time he ceased his involvement in the clinical trial when he left for a
      position at Duke University it was unclear whether MDS was related to
      the trial.
             Elizabeth Reed met with the Shwabs to discuss the clinical trial
      on January 24, 2008, with Dr. Ravindra present for part of that initial
      meeting. Reed was the trial’s clinical research manager, having been in
      that role for a few months following prior experience at Jewish Hospital
      and eighteen years at the Kentucky Organ Donor Affiliates. She recalled

      17 While Hoofnel involved a claim of medical battery arising from surgery for
removal of a colon tumor wherein the patient disputed also giving consent for removal
of her ovaries and uterus if necessary, this recognition of the importance of an
informed consent document applies equally in a medical negligence/informed consent
case. The consent form signed by Brooke is crucial to the analysis of the informed
consent process.
      18 Chimerism means that the transplant recipient has a mixture of the donor
and recipient’s immune systems. The informed consent form explains that Brooke
would receive a stem cell transplant from her kidney donor, Mack. Therefore, Brooke
would have two types of bone marrow, hers and Mack’s, called “mixed chimerism.”
See also Stedmans Medical Dictionary (2014) (“Chimerism” is defined as “the state of
being chimera” and “chimera” is defined as “[a]n organism that has received a
transplant of genetically and immunologically different tissue, such as bone marrow.).

                                          17
this first meeting and stated that she had the informed consent form
with her because she used it as an educational tool to describe the trial.
The Shwabs asked Reed questions and she estimated that she spent
fifteen to twenty minutes with them this first time. Reed testified that
she discussed the risks listed in the informed consent form in great
detail and emphasized to the Shwabs that in a Phase I trial the
researchers do not know what may happen. Importantly, she testified
that she gave the Shwabs the informed consent form to take home and
read because their protocol required her to do so. She explained that,
because it was a Phase I clinical trial with unknown risks, it was
important that patients fully understand the informed consent. She also
gave them the brochure created by Dr. Ildstad that described the clinical
trial.
       Reed denies that she ever told the Shwabs that the worst thing
that could happen is that the protocol would not work, and that Brooke
would have to take anti-rejection medication. She estimated that on
March 10, 2008 when she met with Brooke to sign the consent form that
the process took approximately one hour. When questioned about her
knowledge regarding obtaining informed consent, Reed also explained
that before she began managing the study she was given the trial
protocol and informed consent form, reviewed it, and was able to ask her
predecessor questions about it. Reed also shadowed her predecessor
while she obtained informed consent for the various clinical trials
sponsored by the ICT. She had received additional training on how to
obtain informed consent from Jewish Hospital and her former employer,
Kentucky Organ Donor Affiliates. She also had discussed the clinical
trial protocol and informed consent process during meetings with Drs.
Ildstad, Ravindra and Herzig.
       Dr. Herzig testified that when he met with Brooke he reviewed
issues with her that were included in the informed consent. On the day
Brooke signed the consent form Dr. Herzig meet with her for an
“extended period of time.” He described the process and explained that
when he met with the Shwabs on March 10, 2008 they had already met
with Dr. Ravindra and discussed the protocol. He explained the trial’s
regimen to the Shwabs and discussed the potential complications
involved. He also explained that the protocol had not yet been
successful. As for his training in the informed consent process generally,
he also testified that he had discussions with Dr. Ildstad, Dr. Ravindra
and Reed about how to obtain informed consent for the trial.
       Dr. Silverman testified that he had a lengthy discussion with
Brooke about the purpose, technique and side effects of radiation. Dr.
Silverman testified that it was routine procedure to give patients two
pamphlets, one that detailed the radiation procedure and another
pamphlet that discussed total body irradiation (TBI). The TBI pamphlet
listed “second cancer” as a possible side effect. The purpose of providing
the pamphlets was to allow patients to take the materials home to review
                                18
      and ask questions prior to the procedure. Dr. Silverman specifically
      wrote “second cancer” on the list of possible side effects in the TBI
      consent form and stated that the risk of a second cancer was one of the
      many things he explained to Brooke.19

      Dr. Levitt, the only expert witness the Shwabs disclosed relating to the

consent process, provided his opinions about the informed consent form and

process. He stated that written consent is required but that there should also

be a detailed oral conversation with the patient that describes the risks and

benefits of a procedure, as well as available alternatives. Dr. Levitt testified

that these components of obtaining informed consent are even more important

in the context of a Phase I clinical trial. He testified that he believed the

medical defendants in this case used a flawed written consent form because it

was too lengthy and difficult to follow. Conversely, Dr. Levitt further opined

that the form was not detailed enough because it should have mentioned

specific risks regarding bone marrow, including stem cell damage, leukemia

and MDS. He claimed that MDS is a known side effect when total body

irradiation and chemotherapy are used in conjunction and therefore the risk

should have been included in the consent form.

      Most of Dr. Levitt’s criticism of Brooke’s consent to participate in the trial

stems from the Shwabs’ testimony that they were not given all the necessary

information and simply did not understand the extent of the risks. Notably,

      19 “Second cancer” was referenced because Dr. Silverman primarily used total
body irradiation for patients with either advanced lymphoma or leukemia. Brooke was
one of only three non-cancer patients he had ever treated with TBI. In twenty-two
years of administering TBI he had never seen a patient develop a second cancer.

                                         19
Dr. Levitt did not criticize how the medical defendants conducted the consent

process but instead focused his deposition testimony on the content of the

information as described by the Shwabs in their respective depositions.

      In essence, Dr. Levitt believed the Shwabs came away with the idea that

there was not much bad that could happen from the trial. However, they

received, reviewed and signed the consent form that listed numerous potential

risks and side effects, making it difficult to conceive how the Shwabs (or

anyone for that matter) could believe nothing bad could happen. The

numerous listed risks and side effects also make it difficult to conceive that any

of the medical care providers they met with would have told them nothing bad

would happen, especially given the definition and very nature of a Phase I

clinical trial. As the first page of text in the consent form relates, the trial was

to evaluate “the safety of the procedure”; “the approach . . . has not been done

before”; the “procedure is investigational” and therefore not approved by the

FDA; and the “combined bone marrow procedure is basically untested in

humans.”

      Leaving aside Dr. Levitt’s primary reliance on the Shwabs’ deposition

testimony, his review of the informed consent process was largely incomplete.

While Dr. Levitt reviewed the Shwabs’, Dr. Garcia-Manero’s and Elizabeth

Reed’s depositions, he acknowledged that he did not read Drs. Ravindra’s,

Herzig’s, Silverman’s and Ildstad’s depositions. As noted supra, the Shwabs

also met with Dr. Silverman, Dr. Herzig and Dr. Ravindra to discuss the trial

before Brooke consented to participate and all of these individual defendants

                                         20
were deposed. Dr. Ildstad, the trial’s sponsor involved with drafting the

consent form and materials about the clinical trial, was also deposed. Dr.

Levitt did not consider any of these fact witnesses’ depositions and thus was

unaware of Drs. Ravindra’s, Herzig’s and Silverman’s sworn testimony

regarding their conversations with the Shwabs. When questioned, he admitted

that review of those depositions “could be” pertinent to his opinion regarding

the discussions they had with the Shwabs about the clinical trial and risks. He

even agreed that it would be important to know what everyone says about the

consent process, not just the Shwabs. Although Reed engaged in discussions

with the Shwabs about the clinical trial and was important to the informed

consent process, she did not operate solo. Significantly, Dr. Levitt failed to

review the depositions of the three medical care providers who discussed the

clinical trial with the Shwabs, all of whom were deposed at least three years

prior to Dr. Levitt.

      Returning to the law of informed consent, the crucial component of a

claim under KRS 304.40-320(1) is evidence that a medical care provider’s

actions did not comply “with the accepted standard of medical or dental

practice among members of the profession with similar training and

experience.” “Ordinarily, the failure to comply with a medical profession

standard can only be proven by expert testimony.” Argotte, 521 S.W.3d at 556.

While Dr. Levitt expressed his own personal criticism of the informed consent

form and process, i.e., the informed consent form does not give a patient a

sense of the degree of risk involved and MDS specifically should have been

                                        21
included as a risk and discussed with the Shwabs, he did not testify to an

accepted standard of medical practice and thus did not testify as to a breach of

that standard. It was incumbent upon the Shwabs to “show the physician’s

actions for obtaining consent fell outside ‘the accepted standard of medical . . .

practice.’” Argotte, 521 S.W.3d at 556 (quoting KRS 304.40-320(1)). In

addition to not testifying that the medical defendants deviated from an

accepted standard of care, Dr. Levitt lacked a proper basis for such testimony

given that he did not review depositions of three medical defendants (in fact the

three physicians involved) who discussed the clinical trial with Brooke and

actually provided medical treatment pursuant to the clinical trial protocol.

      While Dr. Levitt noted his substantial clinical trial experience, including

his participation in trials that studied leukemia and MDS, he was unable to

specifically cite any medical literature to support his assertions that the

informed consent process was deficient. The medical defendants’ counsel

specifically asked Dr. Levitt for citations to medical literature that more

accurately reflected the risk of MDS or leukemia. Dr. Levitt stated that he had

not “specifically reviewed the medical literature with regard to this” but that

textbooks on radiation medicine reviewed data on total body irradiation, MDS

and leukemia. He generally referenced studies that reviewed the incidence of

MDS and the increase in incidence when chemotherapy is added. He also

suggested that “most of the literature” indicates that the combination of total

body irradiation and chemotherapy causes an increased risk of leukemia and

MDS but did not cite any particular medical treatise or publication.

                                        22
      Stated simply, Dr. Levitt’s testimony failed to qualify as expert testimony

necessary to satisfy KRS 304.40-320(1). He did not possess all the relevant

information regarding the various discussions with medical care providers and

instead resorted almost entirely to the Shwabs’ testimony regarding the

informed consent process. KRS 304.40-320(1) requires more than one

physician’s personal opinion regarding how he believes informed consent

should work. Dr. Levitt’s testimony simply does not constitute evidence that

“the [medical defendants’] actions for obtaining consent fell outside ‘the

accepted standard of medical . . . practice.’” Argotte, 521 S.W.3d at 556

(quoting KRS 304.40-320(1)).

      While the Shwabs did not meet their burden under KRS 304.40-320(1),

we note that it would be a difficult task for any plaintiff given the extra vetting

that occurs where informed consent is sought in the context of a clinical trial

subject to federal regulation. Title 21 C.F.R. § 50.25 outlines the information

that must be contained within a valid informed consent form:

      (a) Basic elements of informed consent. In seeking informed
      consent, the following information shall be provided to each
      subject:

             (1) A statement that the trial involves research, an
             explanation of the purposes of the research and the expected
             duration of the subject’s participation, a description of the
             procedures to be followed, and identification of any
             procedures which are experimental.

             (2) A description of any reasonably foreseeable risks or
             discomforts to the subject.

             (3) A description of any benefits to the subject or to others
             which may reasonably be expected from the research.

                                         23
             (4) A disclosure of appropriate alternative procedures or
             courses of treatment, if any, that might be advantageous to
             the subject.

             (5) A statement describing the extent, if any, to which
             confidentiality of records identifying the subject will be
             maintained and that notes the possibility that the Food and
             Drug Administration may inspect the records.

             (6) For research involving more than minimal risk, an
             explanation as to whether any compensation and an
             explanation as to whether any medical treatments are
             available if injury occurs and, if so, what they consist of, or
             where further information may be obtained.

             (7) An explanation of whom to contact for answers to
             pertinent questions about the research and research
             subjects’ rights, and whom to contact in the event of a
             research-related injury to the subject.

             (8) A statement that participation is voluntary, that refusal to
             participate will involve no penalty or loss of benefits to which
             the subject is otherwise entitled, and that the subject may
             discontinue participation at any time without penalty or loss
             of benefits to which the subject is otherwise entitled.

(Emphasis added.) The clinical trial Brooke participated in would not have

been allowed to proceed absent compliance with this regulation. Particularly of

note in the context of this litigation is subsection (2) requiring disclosure of all

“reasonably foreseeable risks.”

      As for the particular informed consent form Brooke signed, the record

reflects that Dr. Ildstad, Dr. Ravindra and Dr. Herzig collaborated to draft the

consent form at an eighth-grade reading level to make it easy to understand.

The initial draft of the consent form was then provided to the FDA for review.

The form was next sent to a local IRB, which is a group formally designated to

                                         24
review and monitor biomedical research involving human subjects.20 An IRB

has the authority to approve, require modifications, or disapprove research.

The U.S. Department of Defense’s own IRB also reviewed the informed consent

form because the Department of Defense provided funding for the clinical trial.

The Department of Defense reviewed the consent form and trial protocol to

ensure both were in accordance with federal regulations.

      Dr. Ildstad’s testimony that the informed consent form was “very

thoroughly reviewed” through a “very tedious process” is not surprising given

the various layers of oversight in a clinical trial. In sum, Brooke signed a

consent form that was drafted and reviewed not only by three medical care

providers in Kentucky but also reviewed and approved by the FDA, two IRBs

and the U.S. Department of Defense. Given these circumstances, the prospect

of a deficient informed consent form that did not conform with the “accepted

standard of medical . . . practice,” KRS 304.40-320(1), is miniscule, at best. In

any event, the record reflects no expert testimony regarding the accepted

standard of medical practice and a breach of that standard and, as a result,

the trial court properly granted summary judgment as to the medical

defendants’ compliance with KRS 304.40-320(1).

      20  Institutional Review Boards Frequently Asked Questions, FDA (January 1998),
https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/institutional-review-boards-frequently-asked-questions. The local IRB
that reviewed the informed consent is based in Olympia, Washington and serves as the
IRB for the University of Louisville.

                                         25
      II. The Information Conveyed by the Medical Defendants
          Satisfied Subsection Two of the Informed Consent Statute.

      KRS 304.40-320(2) requires that the medical defendants provide

information that would give “a reasonable individual . . . a general

understanding of the procedure” and also “medically . . . acceptable alternative

procedures or treatments and substantial risks and hazards inherent in the

proposed treatment” as “recognized among other health care providers who

perform similar treatments or procedures.” The Sargent Court explained that

            [s]ubsection (2) covers the content of “the information
            provided,” and it sets forth the objective standard that “a
            reasonable individual” must have from that information a
            “general understanding” of the risks “recognized among
            health care providers who perform similar
            treatments[.]” KRS 304.40-320(2).

467 S.W.3d at 209 (emphasis added). Pursuant to the statute the medical

defendants were required to inform Brooke of the substantial risks inherent in

the clinical trial treatment and the information provided must be evaluated

from the standpoint of “a reasonable individual,” not Brooke’s subjective

understanding or memory.

      The consent form warned that “[t]here may be unknown risks, which are

not known at this time”; “[i]t is not possible to be informed of every possible

complication or risk”; that the procedure was “basically untested in humans”;

that she would “be one of the first groups to be treated”; and that “the

approach in this trial using X-ray therapy and facilitator cells has not been

done before.” (pp. 2, 6 and 7.) The consent form further plainly identified

cancer as a potential risk of the trial, including listing cancer as a risk under

                                        26
the total body irradiation section as well as the stem cell transplantation

section of the consent form. The form also included the following statements:

      [b]esides weakening your body’s ability to fight infection, they can
      also cause high blood pressure, kidney damage, and possibly
      cancer. (p. 4)
      ....

      There is also a very low risk of developing a cancer related to the
      radiation during the course of your lifetime. This risk is estimated
      based on studies of one time exposure to low levels of radiation to
      be less than or equal to 2%. (p. 5)

      ....

      These delayed effects may include certain types of cancer. (p. 8)

(emphasis added). The form specifically informed the Shwabs that

participation in the trial was voluntary and that they could “choose not to enter

the trial and instead receive standard therapy” for Brooke’s condition. In the

separate consent form for the radiation therapy Brooke acknowledged that

“second cancer” was a potential risk of the treatment. From an objective

viewpoint, the multiple references during the consent process through the

written form and discussions adequately conveyed that cancer was a risk of the

treatment protocol.

      The fact that MDS was not specifically listed in the consent form, despite

Dr. Levitt’s testimony that it should have been included as a risk, does not

render the informed consent invalid. No other patient who participated in the

trial had developed MDS.21 Additionally, expert testimony established that

      21 The Shwabs assert that Brooke was the very first research subject in this
Phase I clinical trial. At the time Brooke participated in the trial it had been ongoing
since 2003 and had ten to twelve participants prior to Brooke. When Brooke
                                           27
MDS is typically developed by older males, not young females like Brooke. The

Shwabs’ own expert witness, Dr. Garcia-Manero, testified that “not everyone

that is exposed to these chemoradiation therapies will get this disorder. . . . It’s

actually a minority” of “less than five percent of patients.” The Leukemia and

Lymphoma Society states that, “[a] small number of patients who have received

chemotherapy and/or radiation therapy in the past for another cancer have a

small risk of developing treatment-related MDS. Generally, the chance of

developing a myelodysplastic syndrome as a result of treatment for another

cancer is very low.”22 Given the low prevalence of MDS and the fact that no

other patient in the trial or similar studies had developed MDS, this specific

cancer could not constitute a substantial risk under Kentucky informed

consent law and, in fact, no expert testified as such.23

      The Shwabs insist that the issue of “substantial risk” is for the jury and

does not require expert testimony. We briefly review the two cases relied on to

clarify the law. In Sargent, the trial court erroneously instructed the jury by

failing to incorporate the requirements of KRS 304.40-320 applicable to a

medical provider’s duty to obtain informed consent. 467 S.W.3d at 212. The

participated in the trial in 2008 she was the first subject under the particular protocol
which used the sequential method of total body irradiation and fludarabine.
      22Myelodysplastic Syndromes, LEUKEMIA AND LYMPHOMA SOCIETY,
https://www.lls.org/booklet/myelodysplastic-syndromes (last updated 2019).
       23 See Goodman v. U.S., 298 F.3d 1048, 1058 (9th Cir. 2002), where a clinical

research study participant was not informed of the complication from which she
ultimately died. The federal appellate court held that the physicians had no reason to
know there was a risk of that complication as no study participants had previously
suffered that complication. The record supported “the conclusion that the NIH doctors
were not, and could not reasonably have been, aware . . .” of the unperceived risk. Id.

                                           28
Court explained that jurors can apply the “reasonable individual” and “general

understanding” standards provided in subsection (2) of KRS 304.40-320, but

that “evidence on whether the ‘risks and hazards’ involved are among those

‘recognized among other health care providers who perform similar treatments

or procedures’” is required. Id. at 209. Notably, the majority in Sargent failed

to state “substantial risks and hazards,” the language of the statute, in

explaining what is required in the medical evidence. This Court’s reference to

the ability of the jurors to apply the law, moreover, was focused on determining

if a reasonable individual would have a general understanding of the

information provided not on their ability to know whether a particular risk was

substantial or not. In Argotte, a 4-3 decision, the majority stated that proving

a failure to comply with KRS 304.40-320 “requires an expert opinion only as

needed to establish “whether the ‘risks and hazards’ involved [in the plaintiff’s

claim] are among those ‘recognized among other health care providers who

perform similar treatments or procedures.’” 521 S.W.3d at 556 (quoting KRS

304.40-320(2)). Once again the majority omitted “substantial,” which is crucial

to correct application of the statute.

      As Justice Keller explained in a separate opinion (joined by two other

Justices) in Argotte, KRS 304.40-320(2) expressly states that the risks to be

disclosed must have been “substantial risks.” 521 S.W.3d at 562 (Keller, J.,

concurring in part and dissenting in part). The dissenters did not believe “a

jury of laypersons, without guidance from providers who perform similar

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

                                         29
whether a risk is substantial.” Id. Indeed, determining whether a particular

risk is substantial is not only a matter best addressed by the medical

community and therefore an element requiring expert testimony, but that is

what a plain reading of KRS 304.40-320(2) requires, i.e., “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.” To the extent that Sargent and Argotte suggest that the

substantiality of a risk is a jury question that does not depend on medical

evidence those holdings are overruled. Under the informed consent statute,

the Shwabs’ claim, premised on a failure to disclose the risk of MDS, required

expert testimony establishing that MDS was a recognized substantial risk and

they had no such testimony. In any event, to the extent that cancer generally

was a substantial risk associated with the treatment in the clinical trial, that

risk was appropriately disclosed numerous times.

      Dr. Levitt testified that the Shwabs did not understand the risks involved

in the clinical trial, relying on the Shwabs’ subjective testimony. In Sargent,

however, this Court emphasized that subsection (2) of KRS 304.40-320 creates

an objective standard: “Meeting the standard does not require that

patient’s actual understanding of the risks; it only requires that the risks be

explained so that ‘a reasonable individual’ would gain a general understanding

of the risks.” 467 S.W.3d at 208 n.10. Thus our informed consent law does

not require a determination of how the plaintiff-patient claims to have

understood the consent form, procedure and risks but rather how a reasonable

                                        30
person would have understood the information.24 Consequently, the standard

in subsection (2) is not met by a plaintiff-patient, after the fact, simply claiming

they were not properly informed or that, had they known of the specific risk

that resulted in actual harm, they would not have consented to the treatment

or procedure.25

      As noted in the concurring in result only opinion in Sargent, 467 S.W.3d

at 218, KRS 304.40–320 was enacted as part of a tort-reform effort and was

produced by the Governor’s Hospitals and Physicians Professional Liability

Insurance Advisory Committee in 1975. In the Committee’s Majority Report,

they describe the statute (Section 13 of their proposal and eventually Section 4

of Senate Bill 248 in the 1976 Session of the General Assembly) as follows:

      This section will legislatively require that “informed consent” cases
      be proven by expert testimony relating to accepted standards of
      practice of the profession in providing information, and further
      require that an objective standard be applied in determining
      whether that information would likely have resulted in any
      different decision by the plaintiff. The purpose of this section is to
      eliminate the possibility of (1) a jury’s speculating after the fact
      that the health care provider should have told the plaintiff of a
      given risk even though accepted professional standards would not
      require such advance information, and (2) a plaintiff's testifying

      24Some jurisdictions have held that under an objective approach, a patient’s
hindsight testimony is relevant, but not controlling. See Goldberg v. Boone, 912 A.2d
698, 702 (Md. 2006); Roybal v. Bell, 778 P.2d 108, 112 (Wyo. 1989).
      25  If the informed consent standard were subjective then a plaintiff-patient’s
testimony would control. Proof of causation, i.e., that adequate disclosure would have
caused the patient to decline treatment because of the risk that resulted in actual
harm, viewed under a subjective standard “would ultimately turn on the credibility of
the hindsight of a person seeking recovery after he had experienced a most
undesirable result. Such a test puts the physician in ‘jeopardy of the patient’s
hindsight and bitterness.’” Sard v. Hardy, 379 A.2d 1014, 1025 (Md. App. 1977)
(quoting Canterbury v. Spence, 464 F.2d 772, 790-91 (D.C. Cir. 1972)) (internal
citation omitted).

                                          31
      that had he known of an unforeseeable or unlikely injury he would
      not have consented to the recommended health care.

As this passage reflects, the informed consent statute was enacted, at least in

part, to prevent the type of hindsight scenario present in this case.

      The Shwabs did not present evidence that the information given to

Brooke failed to provide a reasonable person a “general understanding” of any

“substantial risks” that were “recognized among other health care providers”

performing similar research and treatment. Moreover, our own review, like the

trial court’s, satisfies us that no issue of material fact exists as to the

applicability of subsection (2) of KRS 304.40-320 to this case. MDS was not a

“substantial risk” at the time Brooke entered the trial given its low prevalence

generally in young females, and the fact that no other patient in the clinical

trial or similar study had developed MDS. In any event, a reasonable person

would certainly understand from even a casual reading of the informed consent

form that developing cancer (of which MDS is one type) was a risk of the

clinical trial procedure and treatment.

      III. KRS 304.40-320 Is Clear in Its Application to Any Action
      Wherein Informed Consent Is an Element and Thus Applies Even if
      Medical Treatment Occurs in a Clinical Trial.

      The medical defendants and amici curiae American Medical Association

and Kentucky Medical Association emphasize the importance of clinical trials

for the advancement of medicine and the chilling effect that a subjective

approach to liability, as reflected in the Court of Appeals’ opinion in this case,

would have on medical professionals’ participation in studies essential for

improving medical care. In recognition of the unique nature of clinical trials,
                                          32
the medical defendants encourage this Court to conclude that Kentucky’s

informed consent law does not apply to clinical trials because no physician-

patient relationship exists. We decline because we conclude that a physician-

patient relationship clearly does exist, at least in the circumstances presented

here, and our Kentucky informed consent law, tied to standards of accepted

medical practice and an objective assessment of the information provided to

the patient, adequately protects the interests of both patients and medical care

professionals participating in a clinical trial.

      In Greenberg v. Miami Children’s Hospital Research Institute, Inc., the

case relied on by the medical defendants, the federal court observed that

“[m]edical consent law does not apply to medical researchers.” 264 F. Supp. 2d

1064, 1069 (S.D. Fla. 2003). However, the facts of that case are significantly

different from cases such as this one which entail receiving medical treatment

in the context of a clinical trial. Greenberg involved the families of children

with a rare genetic condition who donated tissue samples to a medical

researcher in hopes of identifying the gene responsible for their disorder. Id. at

1066. Once the researcher identified the genes, he applied for a patent and

began restricting any activity related to the disorder, including testing,

treatments and research. Id. at 1067. The Greenberg plaintiffs filed suit

alleging they were never informed that the medical researcher intended to seek

a patent on the research or of his intentions to commercialize the research. Id.

at 1068. The suit included a claim of lack of informed consent, among other

claims. Id. The court acknowledged that the question of informed consent in

                                         33
the context of medical research was relatively novel in Florida but concluded

that while “in certain circumstances a medical researcher does have a duty of

informed consent” no such duty existed there. Id. at 1070. The Shwabs assert

that Greenberg is inapplicable because it involved a dispute over financial

proceeds of non-therapeutic testing. Id. at 1068-69. We agree Greenberg is

distinguishable and find the Kentucky informed consent statute on its face

applies to a clinical trial involving medical treatment.26

      The informed consent statute plainly applies to “any action brought for

treating, examining, or operating on a claimant wherein the claimant’s

informed consent is an element.” KRS 304.40-320 (emphasis added). KRS

304.40-260(4) includes “patient” in its definition of “claimant” and “patient” is

defined as “a natural person who receives health care from a licensed health

care provider under a contract, express or implied.” KRS 304.40-260(3).

Health care is defined as “any act, or treatment performed or furnished, or

which should have been performed or furnished, by any health care provider to

a patient during that patient’s care, treatment, or confinement for a physical or

mental condition. . . .” KRS 304.40-260(7).

      Brooke qualifies as a claimant and the treatment she received during the

clinical trial undeniably constitutes health care. The language in KRS 304.40-

      26The Court of Appeals declined to review this issue, stating that it was not
decided upon by the trial court and citing Fischer v. Fischer, 197 S.W.3d 98, 102 (Ky.
2006). While the trial court did not discuss this issue in its order granting summary
judgment, the medical defendants presented the argument in their motion for
summary judgment and the issue has been briefed to this Court.

                                          34
320 and 304.40-260 is clear and unequivocal. Where a statute is clear and

unambiguous, “we are not free to construe it otherwise . . . .” MPM Fin. Grp.,

Inc. v. Morton, 289 S.W.3d 193, 197 (Ky. 2009). While the Kentucky General

Assembly could have deferred to federal authorities such as the FDA in

defining the informed consent duty in a clinical trial or articulated a different

standard for informed consent in clinical trials, it did not. Because the

judiciary’s role in statutory construction cases is to see that “the will of the

legislature” is applied, Allstate Ins. Co. v. Smith, 487 S.W.3d 857, 861 (Ky.

2016), we decline to impose a different standard of informed consent for clinical

trials.

                                     CONCLUSION

          As the trial court stated in its order granting summary judgment, this is

“an unquestionably tragic situation for Ms. Shwab and her family,” but for the

reasons we have discussed the Shwabs do not have a viable informed consent

claim under Kentucky law. Thus, we reverse the Court of Appeals and remand

to the trial court for reinstatement of the summary judgment in favor of the

Appellants.

          All sitting. All concur.

                                          35
COUNSEL FOR APPELLANTS:

Allison Olczak Wildman
Joseph Andrew Wright
Thompson Miller & Simpson PLC

COUNSEL FOR APPELLEES:

David Brooks Gray
Gray Law, PLLC

COUNSEL FOR AMICUS CURIAE,
KENTUCKY DEFENSE COUNSEL
INC.:

Patricia Colleen LeMeur
Phillips Parker Orberson Arnett, PLC

COUNSEL FOR AMICI CURIAE,
THE AMERICAN MEDICAL
ASSOCIATION AND THE
KENTUCKY MEDICAL
ASSOCIATION:

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

Philip S. Goldberg
Shook, Hardy & Bacon LLP

                                       36