Court Opinion

ID: 2801710
Source: CourtListenerOpinion
Date Created: 2015-05-19 09:06:09.495496+00
Date Added: 2024-06-11T11:36:17.496848
License: Public Domain

IN THE SUPREME COURT OF TENNESSEE
                            AT KNOXVILLE
                               November 3, 2014 Session

                  IKE J. WHITE III v. DAVID A. BEEKS, M.D.

          Appeal by Permission from the Court of Appeals, Eastern Section
                        Circuit Court for Bradley County
                      No. V07554 J. Michael Sharp, Judge

                  No. E2012-02443-SC-R11-CV – Filed May 18, 2015

The issue in this health care informed consent case is whether the trial court erred by
limiting the testimony of plaintiff patient’s expert witness regarding the risks that the
defendant doctor was required to disclose to obtain the patient’s informed consent for
surgery. The doctor performed a spinal fusion on the patient. His back pain initially
improved, but subsequently worsened. The patient sued the doctor, claiming his back
pain was caused by nerve compression due to ectopic bone growth at the site of the
fusion. The patient alleged that the doctor failed to give him adequate information to
enable him to give an informed consent to the surgery. In a pretrial deposition, the
patient’s expert testified that to obtain informed consent, the doctor was required to
advise the patient that he would use a bone-grafting protein and inform the patient about
all the potential risks arising from its use, including risks that allegedly caused harm and
risks that did not cause harm. The trial court granted the doctor’s motion to limit the
patient’s expert witness testimony to only those risks that allegedly materialized and
injured the patient. The jury returned a verdict in favor of the doctor. In a divided
opinion, the Court of Appeals affirmed the trial court’s exclusion of the expert medical
testimony. We hold that the trial court erred by excluding expert testimony regarding
undisclosed medical risks that had not materialized. Because this error, more probably
than not, influenced the jury’s verdict, the patient is awarded a new trial.

   Tenn. R. App. P. 11 Appeal by Permission; Judgment of the Court of Appeals
                                    Reversed

SHARON G. LEE, C.J., delivered the opinion of the Court, in which CORNELIA A.
CLARK, GARY R. WADE, JEFFREY S. BIVINS, and HOLLY KIRBY, JJ., joined.

H. Franklin Chancey, Cleveland, Tennessee, for the appellant, Ike J. White III.

Richard A. Smith and Stacy Lynn Archer, Chattanooga, Tennessee, for the appellee,
David A. Beeks, M.D.
                                              OPINION

                                                    I.

        Ike J. White III, aged nineteen, had suffered from back pain for over a year. His
pain affected his mobility and sleep, and he was unable to work or continue his
education. In January 2006, Mr. White sought treatment from Dr. David A. Beeks, an
orthopedic surgeon then practicing in Cleveland, Tennessee. In May 2006, after
conservative treatment was unsuccessful, Dr. Beeks operated on Mr. White’s lower back,
fusing select discs and joints to stabilize the spine by using the bone-grafting product,
InFuse.1 Mr. White’s back pain initially improved. Approximately six weeks after
surgery, however, Mr. White again reported significant lower back pain. Subsequent
tests indicated that ectopic or abnormally placed bone had formed at the site of the
surgery.
       On July 13, 2007, Mr. White filed a health care liability suit against Dr. Beeks in
the Bradley County Circuit Court.2 In an amended complaint, Mr. White alleged that Dr.
Beeks had failed to obtain Mr. White’s informed consent to the surgery by not advising
Mr. White of his intention to use InFuse, the manner in which it would be used, or the
risks associated with its use. Mr. White’s informed consent claim was centered on the
theory that Dr. Beeks’ use of InFuse caused the ectopic bone growth, which, in turn,
caused pressure to be placed on a nerve in Mr. White’s back. This pressure on the nerve
was alleged to be causing Mr. White’s continued back pain.
        In a pretrial deposition, Mr. White’s expert medical witness, Dr. Melvin Law,
testified that based on his personal experience treating patients, the use of InFuse had
caused ectopic bone growth in one case; a cystic lesion, which is an inflammatory
reaction, in probably ten cases; and postoperative radiculitis or fluid collection in fifteen
to twenty percent of patients. Dr. Beeks moved to limit Dr. Law’s trial testimony
regarding the risks of surgery that should have been disclosed to only those risks that
materialized and allegedly caused harm, and to exclude testimony about the potential

        1
         InFuse is a human-engineered ―bone morphogenic protein, which is designed to stimulate bone
growth and promote fusion.‖ White v. Beeks, No. E2012-02443-COA-R3-CV, 2013 WL 6451764, at *1
(Tenn. Ct. App. Dec. 9, 2013).
        2
          The complaint alleged that Dr. Beeks breached the recognized standard of acceptable medical
practice by failing to exhaust more cautious remedies before performing surgery, by performing a risky
surgical procedure, by failing to perform proper follow-up care, and by failing to diagnose Mr. White’s
postsurgical condition in a timely manner. The jury found in favor of Dr. Beeks, and this ruling is not an
issue on appeal.

                                                   -2-
risks that did not occur. Dr. Beeks contended those risks were not relevant under
Tennessee Rule of Evidence 401 and would potentially be prejudicial to him under
Tennessee Rule of Evidence 403. In response, Mr. White argued that the jury should
hear all of the risks. The trial court granted the motion and limited Dr. Law’s testimony
to only those risks associated with InFuse that allegedly occurred and caused an injury to
Mr. White.

       A jury trial was conducted over four days in August 2012. Mr. White testified that
he had suffered back pain stemming from three separate incidents.3 Mr. White testified
that he had trouble walking, touching his toes, and sleeping more than four hours a night
because of his pain. In addition, Mr. White was unable to work or continue his
education. Mr. White took over-the-counter pain medications and used heating pads and
ice packs to reduce his pain. After the pain became too much to bear, Mr. White went to
the emergency room in January 2006. That same month, he sought treatment from Dr.
Beeks, who examined Mr. White, reviewed his x-rays, and recommended physical
therapy.

       Mr. White testified that physical therapy did nothing to ease his pain, which
included a sensation like a ―lightning bolt shooting down [his] leg.‖ When he visited Dr.
Beeks for a follow-up appointment on February 3, 2006, Mr. White ranked his pain a 10
out of 10,4 and he told Dr. Beeks that physical therapy was not helping his ongoing pain.
As a result, Dr. Beeks ordered an MRI of the lumbar spine, which showed a degenerative
disc with herniation. Dr. Beeks reviewed the results with Mr. White and told him he had
a herniated disc pushing on one of his nerve roots. Dr. Beeks recommended that Mr.
White undergo a surgical fusion because surgery was the only viable option at that point.5

        Surgery was scheduled, but Mr. White cancelled it to get a second opinion. Dr.
Beeks referred Mr. White to Dr. Stephen Dreskin for pain management and to discuss
nonsurgical treatment. Mr. White testified that he had rated his pain level ―an 8 or a 9 out
of 10‖ when he met with Dr. Dreskin, who subsequently gave him an epidural steroid
injection in his back. Because this injection made him feel worse, Mr. White did not

       3
          Before seeking any medical treatment, Mr. White had fallen down a flight of stairs at his
mother’s house, hurt himself lifting a 200-pound car transmission, and had an accident on a
three-wheeler. Mr. White testified that his back hurt worse after the three-wheeler accident than it had
hurt between the two prior accidents.
       4
           According to Mr. White’s testimony, 10 out of 10 meant ―the worst pain‖ on the scale used.
       5
          Mr. White testified that he did not believe that he took notes during this meeting, but was
―pretty sure‖ he could recall everything Dr. Beeks had told him that day.

                                                    -3-
schedule a second epidural steroid injection.      Dr. Dreskin recommended surgery to
address Mr. White’s ongoing pain.

        Mr. White returned to Dr. Beeks’ office, and they again discussed surgery. As Mr.
White recalled, Dr. Beeks ―said he was going to put a rod and two screws in it and some
kind of fake bone mass.‖ Mr. White stated, however, that Dr. Beeks never told him what
that meant, never used the word ―InFuse,‖ and never talked to him about any of the risks
involved. Mr. White also testified that Dr. Beeks did not discuss with him whether it was
necessary to use the artificial bone mass or the prospects for a successful surgery if the
artificial bone mass was not used. Dr. Beeks spoke to him about the basic risks of
surgery, ―like . . . not wak[ing] up.‖ However, Mr. White denied ever being told that Dr.
Beeks intended to ―use a product to help [his spinal] fusion grow.‖ Dr. Beeks told him
that there was a seventy percent chance the surgery would help him and a thirty percent
chance it would not. Dr. Beeks gave Mr. White an opportunity to ask questions, and Mr.
White inquired about his recovery, how long he would be in the hospital, and how much
pain he would have. On May 2, 2006, Dr. Beeks operated on Mr. White’s lower back,
fusing his spine.

        According to Mr. White, his back pain improved after surgery, but soon the pain
returned, including ―a real sharp drilling kind of pain every time [he] put any pressure on
[his] right leg, [and a] fuzzy lightning bolt kind of feeling . . . down [his] right leg.‖
Subsequent tests indicated that ectopic bone had formed at the site of the surgery. Mr.
White elected not to undergo additional surgery to remove the bone growth.
        Dr. Law testified that Dr. Beeks failed to provide the information required by the
standard of care in order to obtain Mr. White’s informed consent to the surgery. He
explained that Dr. Beeks was obliged to discuss the rationale for the surgery and the
alternative treatments or alternative types of surgery, which included simple
decompression without fusion or other types of fusion procedures. Dr. Law opined that
Dr. Beeks should have explained to Mr. White that he had the option of deciding whether
to use InFuse during surgery. In addition, Dr. Law said that Dr. Beeks should have
described the relative advantages of InFuse, the complications associated with its use, the
potential to increase the chance for a successful fusion when using InFuse versus not, and
the manner in which InFuse would be used. Further, Dr. Law stated that Dr. Beeks
should have explained the risks of performing a fusion, as opposed to a simpler type of
decompression procedure. Notably, Dr. Law testified that Dr. Beeks should have
disclosed to Mr. White that the main risks of using InFuse were nerve pain, irritation, and
ectopic bone growth. Consistent with the trial court’s pretrial order, Dr. Law did not
testify as to any other risks, including fluid collection or cystic lesions. Dr. Law admitted
that he does not discuss every possible ―theoretical complication with a patient‖ in order
to obtain informed consent. In Dr. Law’s opinion, the use of InFuse caused ectopic bone

                                             -4-
growth at the site of the fusion, and the bone growth precipitated Mr. White’s
compressive radiculopathy, which caused pain.
       Dr. Beeks testified that he discusses with his patients the risks associated with
medical procedures because he could not expect the typical patient to know of such risks
and ―the patients need to make an informed decision of whether they want to have a
procedure.‖ Dr. Beeks stated that he had given Mr. White enough information so that he
could make an informed decision. Dr. Beeks covered with Mr. White the risk of death,
the possibility of an infection, and the potential for paralysis or increased weakness. The
surgical consent form, signed by Dr. Beeks and Mr. White, stated that Dr. Beeks had
―fully explained the nature and purpose of the operation/procedure, possible alternative
methods of treatment, the risks involved[,] and the possibility of complications.‖
         Though he never specifically mentioned InFuse to Mr. White, Dr. Beeks testified
that he ―would have mentioned that [he was] going to use alternative bone-graft products
to supplement so that [he] didn’t have to go to [Mr. White’s] iliac crest.‖ Dr. Beeks
indicated that he decided not to get into technical specifics because he ―wanted to keep
. . . th[e] discussion as straightforward as possible; and, mostly . . . wanted [Mr. White] to
know what his potential outcomes were.‖ Dr. Beeks did not believe Mr. White needed
―to know the specifics of the metallurgy of the screws or the difference in the hundreds of
different types of bone-grafting options . . . available.‖ As a result, Dr. Beeks focused his
discussion with Mr. White on the general risks that could result from the surgery, such as
the risk of nonunion, the potential for hardware issues, the possibility of not healing, and
the chance of neurological injury. At the time of the surgery, Dr. Beeks was aware
InFuse could cause ectopic bone growth but that it did not result in any neurological
injury.
        Dr. Beeks’ expert medical witness, Dr. Christopher Kauffman, testified that Dr.
Beeks had complied with the standard of care for a surgeon in obtaining Mr. White’s
informed consent for the surgery. According to Dr. Kauffman, informed consent requires
telling patients ―the things that . . . could [a]ffect their ability to get better and get back to
work or their overall health status.‖ Dr. Kauffman indicated that Dr. Beeks had to review
the options available to Mr. White and recommend the procedure that would be most
successful in alleviating Mr. White’s pain without significant complications. Dr. Beeks
had to tell Mr. White about the relevant risks, such as the possibility of an infection or
death, and the risks associated with the recommended type of posterior lumbar interbody
fusion procedure.
       In Dr. Kauffman’s opinion, based upon the leading study on InFuse in 2006—the
year the surgery was performed—there were more benefits to using InFuse than risks, as
compared to using a regular bone graft procedure. InFuse was associated with an
increased incidence of ectopic bone growth; however, the ectopic bone growth had not
been shown to cause neurological problems and, thus, could not be properly labeled a

                                               -5-
―risk‖ of the procedure. Thus, Dr. Kauffman stated that it was not clear whether the
ectopic bone growth actually caused harm to Mr. White, especially because his
presurgical pain mirrored his postsurgical pain. In addition, Dr. Kauffman testified that
Mr. White was a cigarette smoker6 and that smoking hindered the healing process after a
spinal fusion. Dr. Kauffman concluded that he could not say with certainty whether the
ectopic bone growth was causing neurological problems, or if prior nerve aggravation
and the bone’s failure to fuse correctly because of continued smoking were the real
sources of Mr. White’s ongoing pain.
       The jury returned a verdict in favor of Dr. Beeks, and Mr. White appealed, arguing
that he was entitled to a new trial because the trial court had erred by excluding Dr.
Law’s testimony concerning the undisclosed risks that did not occur. A divided panel of
the Court of Appeals affirmed the trial court’s judgment. White, 2013 WL 6451764, at
*9. The majority opinion held that the trial court did not abuse its discretion in limiting
Dr. Law’s testimony, reasoning that any risks that did not ripen into an injury are without
legal consequence. Id. at *8. The dissent opined that the trial court had committed
reversible error by limiting Dr. Law’s testimony because the relevant consideration in an
informed consent case is ―whether or not the health care provider informed the patient of
all significant risks as required to be disclosed to the patient to satisfy the acceptable
standard of care.‖ Id. at *10-12 (Swiney, J., dissenting).
       We granted Mr. White’s application for permission to appeal to decide whether
the exclusion of expert testimony regarding undisclosed risks that had not materialized
constituted an abuse of discretion, and if so, whether the error more probably than not
influenced the jury’s verdict.

                                                  II.

       The doctrine of informed consent attempts to reconcile the tension between a
physician’s desire to do what he or she feels is best for a patient and the patient’s right to
personal autonomy and self-determination over his or her own body. See generally W.
Page Keeton et al., Prosser and Keeton on the Law of Torts § 32 (5th ed. 1984); Ben A.
Rich, Medical Paternalism v. Respect for Patient Autonomy: The More Things Change
the More They Remain the Same, 10 Mich. St. U. J. Med. & L. 87 (2006). Implicit in this
notion of self-determination is the importance of receiving a patient’s consent for any
procedure and the preservation of the patient’s right to make decisions about his or her
medical care. Keeton, supra, at 190. Informed consent developed from the theory of

        6
         At trial, Mr. White testified that he had been a smoker for several years, sometimes smoking as
much as a pack of cigarettes a week. In addition, Mr. White stated, ―The only time I stopped [smoking]
was for about . . . a week when I had my surgery.‖

                                                  -6-
battery, which created a cause of action for a ―nonconsensual, intentional, and offensive
touching of another without lawful justification.‖ Black’s Law Dictionary 182 (10th ed.
2014); see Schloendorff v. Society of N.Y. Hosp., 105 N.E. 92, 93 (N.Y. 1914) (―Every
human being of adult years and sound mind has a right to determine what shall be done
with his own body; and a surgeon who performs an operation without his patient’s
consent commits an assault, for which he is liable in damages.‖).

       Courts established the basic principles of informed consent in the early 1900s,
recognizing that a patient could bring a cause of action against a medical practitioner for
performing an unauthorized medical procedure. See, e.g., Pratt v. Davis, 79 N.E. 562,
565 (Ill. 1906); Mohr v. Williams, 104 N.W. 12, 16 (Minn. 1905). Soon after, this
principle was extended to necessitate consent for medical procedures, requiring that a
physician’s treatment not exceed the patient’s wishes, regardless of what the physician, in
his or her professional judgment, felt was best. See Rolater v. Strain, 137 P. 96, 99
(Okla. 1913).

        In Salgo v. Leland Stanford Jr. Univ. Bd. of Trs., the doctrine of informed consent,
as it is known today, was first articulated. 317 P.2d 170, 181 (Cal. Ct. App. 1957). In
Salgo, the California Court of Appeals examined not only the patient’s consent, or lack
thereof, but also the underlying medical information upon which the patient’s decision
was based. The court held that a physician should make a ―full disclosure‖ of any facts
necessary for a patient’s ―intelligent‖ consent to a proposed treatment, but a physician
should also take into account the patient’s mental and emotional state to decide how
much and what information constituted full disclosure for informed consent. Id. Thus,
Salgo planted the seed of informed consent and signaled the beginning of a slow shift
away from a strict battery theory to a more context-sensitive informed consent theory.

      Over the years, courts have attempted to fill out the contours of the informed
consent doctrine. They have grappled with the required standard of disclosure, see, e.g.,
Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972); defined instances when informed
consent is not possible or not required, see e.g., Pauscher v. Iowa Methodist Med. Ctr.,
408 N.W.2d 355, 360 (Iowa 1987); and explained the standard for causation, see, e.g.,
Adamski v. Moss, 638 A.2d 1360 (N.J. Super. Ct. App. Div. 1994); Mello v. Cohen, 724
A.2d 471 (Vt. 1998). Thus, the doctrine, once rooted in the concept of pure battery,
evolved to become more nuanced and better reflect the realities of medical practice.

       In Tennessee, the doctrine of informed consent has evolved in much the same
manner. This Court first recognized the medical battery cause of action in Butler v.
Molinski. 277 S.W.2d 448, 451-52 (Tenn. 1955) (distinguishing between actions for
negligent malpractice and those premised upon the unauthorized performance of an
operation). Fourteen years later, the Court explained in Ray v. Scheibert that a medical
battery action would result when a ―plaintiff did not effectively consent—therefore, did

                                            -7-
not consent at all—to the operation which the defendant performed.‖ 450 S.W.2d 578,
581 (Tenn. 1969) (emphasis added). On remand in Ray, the Court of Appeals stated that
when no ―informed or knowledgeable‖ consent for a procedure was obtained (and no
exception was applicable), a physician would be liable to a patient for injuries resulting
from the procedure, ―regardless of whether such injuries resulted from negligence or
otherwise.‖ Ray v. Scheibert, 484 S.W.2d 63, 71 (Tenn. Ct. App. 1972).

        In 1974, the Court of Appeals first stated the legal standard for an informed
consent action. Longmire v. Hoey, 512 S.W.2d 307, 309 (Tenn. Ct. App. 1974). In
Longmire, the intermediate appellate court held that in an informed consent claim, the
plaintiff had the burden to show that either the surgical procedure was not actually
authorized or the physician withheld material information regarding the risks involved,
thus preventing the patient from making an intelligent choice when giving consent. Id. at
310. The Longmire court further clarified that in cases where the physician withheld
material information, ―the withheld information must be of such nature as to vitiate any
verbal or written consent given.‖ Id. Nevertheless, the court acknowledged that it would
be humanly impossible to disclose every aspect and risk of a surgery and that such
disclosure would likely prevent a layperson from forming a rational decision. Id.
Thirteen years later, this Court again considered informed consent and, in a narrow
holding, determined that a physician’s deviation from the standard of care would
constitute a battery, because ―the doctrine of battery [is] applicable to cases involving
[treatment] performed without informed or knowledgeable consent.‖ Cardwell v.
Bechtol, 724 S.W.2d 739, 750 (Tenn. 1987) (quoting Ray, 484 S.W.2d at 71) (emphasis
and internal quotation marks omitted).

        In 1998, the Court reaffirmed the Cardwell framework in Shadrick v. Coker,
reiterating, ―the doctrine of lack of informed consent is based upon the tort of battery.‖
963 S.W.2d 726, 732 (Tenn. 1998). The Court held that a health care provider would be
liable for injuries resulting from a procedure performed without informed consent,
regardless of whether those injuries resulted from negligence. Id. Later the same year,
however, the Court, for the first time, severed the theories of medical battery and
informed consent. Blanchard v. Kellum, 975 S.W.2d 522, 524 (Tenn. 1998). The Court
stated, ―[T]here is a distinction between: (1) cases in which a doctor performs an
unauthorized procedure; and (2) cases in which the procedure is authorized but the
patient claims that the doctor failed to inform the patient of any or all the risks inherent in
the procedure.‖ Id. A cause of action alleging an unauthorized procedure sounds in
battery, while one alleging a lack of disclosure for an authorized procedure rests on an
informed consent theory. Id. In cases where the patient has given consent, the inquiry
shifts to examining the information underlying the consent and asks ―whether the doctor
provided any or adequate information to allow a patient to formulate an intelligent and
informed decision when authorizing or consenting to a procedure.‖ Id. (citing Shadrick,
963 S.W.2d at 726). Two years later, the Court of Appeals applied Blanchard and stated

                                              -8-
that an action for informed consent ―does not relate to the manner in which the procedure
was performed, but rather to the manner in which the physician obtained the patient’s
consent to perform the procedure.‖ Church v. Perales, 39 S.W.3d 149, 159 (Tenn. Ct.
App. 2000) (citing German v. Nichopoulos, 577 S.W.2d 197, 202 (Tenn. Ct. App. 1978)).

       Under the Blanchard analysis, Mr. White’s action is not a case of medical battery
because he authorized Dr. Beeks to perform the spinal fusion. Mr. White, however,
claims that Dr. Beeks did not give him the ―full story‖ as to all the risks involved with the
use of InFuse. Dr. Beeks claims that he adequately informed Mr. White of the risks and,
in any case, the harm he suffered was not caused by the procedure. Accordingly, this
claim falls squarely in the realm of informed consent.

      Because this is an informed consent case, Tennessee Code Annotated section
29-26-118, requires that Mr. White prove:

       by evidence as required by § 29-26-115(b)7 that the defendant did not
       supply appropriate information to the patient in obtaining informed consent
       (to the procedure out of which plaintiff’s claim allegedly arose) in
       accordance with the recognized standard of acceptable professional practice
       in the profession and in the specialty, if any, that the defendant practices in
       the community in which the defendant practices and in similar
       communities.

Tenn. Code Ann. § 29-26-118 (2000 & Supp. 2012). Thus, in this case, Mr. White was
required to prove by expert testimony 1) the information that Dr. Beeks should have
disclosed to Mr. White to obtain his informed consent for the surgery, as established by
the recognized standard of acceptable professional practice in the specialty of orthopedic
surgery in Cleveland, Tennessee or similar community; 2) whether Dr. Beeks disclosed
appropriate information to Mr. White to comply with the recognized standard of
acceptable professional practice in the same or similar community; and 3) whether a
reasonable person in Mr. White’s position would have consented to the surgery if he had
been provided with the information required by the recognized acceptable professional
practice. See Ashe v. Radiation Oncology Assocs., 9 S.W.3d 119, 121 (Tenn. 1999). This
last requirement is an objective standard for assessing causation in informed consent
cases and asks the factfinder to decide ―what a prudent person in the patient’s position
would have decided if suitably informed of all perils bearing significance.‖ Id. at 122
(quoting Canterbury, 464 F.2d at 791 (internal quotation mark omitted)); see Tenn. Code
Ann. §§ 29-26-115, -118; see also Blanchard, 975 S.W.2d at 524; Hawk v. Chattanooga

       7
          Tennessee Code Annotated section 29-26-115(b), which discusses who may testify as an expert
witness in a medical malpractice claim, is not at issue in this case.

                                                -9-
Orthopaedic Grp., P.C., 45 S.W.3d 24, 32 (Tenn. Ct. App. 2000) (quoting Shadrick, 963
S.W.2d at 732). The decision a particular patient, such as Mr. White, would have made
had he known all of the risks is relevant, but not controlling. Ashe, 9 S.W.3d at 122
(citing Canterbury, 464 F.2d at 791). The plaintiff must prove each element, and the
actual existence of each element is a question of fact for the factfinder.

                                            III.

                                            A.

       Decisions regarding the admission or exclusion of evidence are generally entrusted
to the sound discretion of the trial court. Mercer v. Vanderbilt Univ., Inc., 134 S.W.3d
121, 131 (Tenn. 2004) (citing Otis v. Cambridge Mut. Fire Ins. Co., 850 S.W.2d 439, 442
(Tenn. 1992)); see also Smartt v. NHC Healthcare/McMinnville, LLC, No.
M2007-02026-COA-R3-CV, 2009 WL 482475, at *13 (Tenn. Ct. App. Feb. 24, 2009)
(holding that the trial court did not abuse its discretion in admitting evidence to prove an
element of the medical malpractice claim after applying the balancing test of Tennessee
Rule of Evidence 403).
        We review a trial court’s decision to admit or exclude evidence under an abuse of
discretion standard. Otis, 850 S.W.2d at 442. A trial court abuses its discretion by
applying an incorrect legal standard or reaching an illogical or unreasonable decision that
causes an injustice to the complaining party. Gonsewski v. Gonsewski, 350 S.W.3d 99,
105 (Tenn. 2011); Brown v. Crown Equip. Corp., 181 S.W.3d 268, 273 (Tenn. 2005);
State v. Gilliland, 22 S.W.3d 266, 270 (Tenn. 2000); State v. Shirley, 6 S.W.3d 243, 247
(Tenn. 1999). In reviewing the trial court’s exercise of discretion, we presume that the
trial court’s decision is correct and review the evidence in a light most favorable to
upholding the decision. Lovlace v. Copley, 418 S.W.3d 1, 16-17 (Tenn. 2013) (quoting
Gonsewski, 350 S.W.3d at 105).            Discretionary decisions, however, require a
conscientious judgment, consistent with the facts, that takes into account the applicable
law. Lee Med. Inc. v. Beecher, 312 S.W.3d 515, 524 (Tenn. 2010).
       Tennessee Rule of Evidence 401 defines relevant evidence as ―evidence having
any tendency to make the existence of any fact that is of consequence to the
determination of the action more probable or less probable than it would be without the
evidence.‖ Tenn. R. Evid. 401. ―[E]vidence is relevant if it helps the trier of fact resolve
an issue of fact.‖ State v. James, 81 S.W.3d 751, 757 (Tenn. 2002) (quoting Neil P.
Cohen, et al., Tennessee Law of Evidence § 4.01[4], at 4-8 (4th ed. 2000)). Tennessee
Rule of Evidence 402 states, ―All relevant evidence is admissible except as [otherwise
provided for by law].‖ Tenn. R. Evid. 402.
       Relevant evidence, however, may be excluded ―if its probative value is
substantially outweighed by the danger of unfair prejudice, confusion of the issues, or

                                            -10-
misleading the jury, or by considerations of undue delay, waste of time, or needless
presentation of cumulative evidence.‖ Tenn. R. Evid. 403; see also Mayo v. Shine, 392
S.W.3d 61, 66-67 (Tenn. Ct. App. 2012) (finding that the probative value of the evidence,
that a patient returned to the same doctor after allegedly suffering harm as a result of the
doctor’s negligence, was outweighed by the potential for prejudice). The plain language
of the rules of evidence ―strongly suggests that when the balance between the evidence’s
probative value and any prejudicial effect is close, the evidence should be admitted.‖
Goodale v. Langenberg, 243 S.W.3d 575, 587 (Tenn. Ct. App. 2007) (citing Richardson
v. Miller, 44 S.W.3d 1, 21 (Tenn. Ct. App. 2000)) (internal quotation marks omitted).
Moreover, ―[e]xcluding otherwise relevant evidence under Tenn. R. Evid. 403 is an
extraordinary step that should be used sparingly.‖ Levine v. March, 266 S.W.3d 426, 439
(Tenn. Ct. App. 2007); see also Wicks v. Vanderbilt Univ., No.
M2006-00613-COA-R3-CV, 2007 WL 858780, at *10 (Tenn. Ct. App. Mar. 21, 2007).
        In his pretrial deposition, Dr. Law testified that the patient should be told of the
following risks associated with InFuse: ectopic bone growth and different types of
possible responses in the patient, specifically cystic lesions behind the spine, radiculitis,
and fluid collection. According to Dr. Law, both cystic lesions and fluid collection
would have necessitated additional procedures and/or surgery. Based on the pretrial
order, Dr. Law testified at trial only to the risks of ectopic bone growth and
―inflammatory reactions, that can cause continued nerve pain.‖ He was not allowed to
testify about any other risks, including details of the specific inflammatory reactions, or
additional procedures that these risks might have required.
       A prudent person needs to be informed of all ―perils bearing significance‖ in order
to give informed consent. See Ashe, 9 S.W.3d at 122 (quoting Canterbury, 464 F.2d at
791) (internal quotation mark omitted). ―Perils bearing significance‖ necessarily include
those perils that caused harm and those that did not. The fact that a risk did not
materialize does not make it less of a risk. At the time a patient is making a decision
whether to undergo a medical procedure, he needs to know prospectively the risks he is
facing—not just those risks that in hindsight materialized and caused him harm. The fact
that a risk did not materialize during or after surgery is not a determining factor in
whether it should have been disclosed to a patient before surgery. Accordingly, the jury
should have been allowed to hear Dr. Law’s complete testimony about the risks of
InFuse, as this evidence would have been relevant under Tennessee Rule of Evidence 401
in the jury’s assessment of what a prudent person would have decided if properly
informed of all the significant risks.
       Even though the evidence is relevant under Rule 401, it could still be inadmissible
under Rule 403, if its ―probative value is substantially outweighed by the danger of unfair
prejudice, confusion of the issues, or misleading the jury, or by considerations of undue
delay, waste of time, or needless presentation of cumulative evidence.‖ We hold that the
excluded evidence was highly probative on the issue of whether a prudent person in Mr.

                                            -11-
White’s position would have consented to the procedure despite the risks. These risks
were neither remote nor highly speculative. We do not conclude that there was danger of
unfair prejudice, confusion of issues, or that the introduction of Dr. Law’s testimony as to
the additional risks would have been cumulative or caused undue delay. Accordingly,
Dr. Law’s complete testimony about the risks of InFuse was relevant, under Tennessee
Rule of Evidence 401, to the jury’s assessment of what a prudent person would have
decided if properly informed of all the significant risks, and the trial court erred by
conditioning inclusion of the evidence on whether the undisclosed risks actually
occurred.

                                             B.

        Having concluded the trial court erred in excluding the evidence, we must now
determine whether the error was harmful and warrants reversal. An erroneous exclusion
of evidence is harmful ―when considering the whole record, error involving a substantial
right more probably than not affected the judgment or would result in prejudice to the
judicial process.‖ See In re Estate of Smallman, 398 S.W.3d 134, 152 (Tenn. 2013)
(quoting State v. Gomez, 367 S.W.3d 237, 249 (Tenn. 2012)) (internal quotation marks
omitted); see also Tenn. R. App. P. 36(b). In a jury case, we must carefully examine the
entire record to determine ―whether [exclusion] of the evidence, more probably than not,
influenced the jury’s verdict.‖ See Smallman, 398 S.W.3d at 152 (―[W]hether [the
evidentiary error] is sufficiently prejudicial to require reversal depends on the substance
of the evidence, its relation to the other evidence, and the peculiar facts and
circumstances of the case.‖). We do not act as a second jury by combining our
harmlessness inquiry with our own assessment of liability. State v. Rodriguez, 254
S.W.3d 361, 373-74 (Tenn. 2008). Rather, the goal is to identify the actual basis for the
jury’s decision, State v. Mallard, 40 S.W.3d 473, 489 (Tenn. 2001) (quoting Momon v.
State, 18 S.W.3d 152, 168 (Tenn. 1999)), and to determine whether the exclusion of
evidence, more probably than not, affected the verdict. Smallman, 398 S.W.3d at 152.

        The jury was required to determine what information Dr. Beeks was obligated to
disclose to Mr. White in accordance with the recognized standard of care, whether Dr.
Beeks deviated from the standard of care by not disclosing adequate information to Mr.
White, and whether a reasonable person in Mr. White’s position, adequately informed of
the risks inherent in the use of InFuse, would have consented to its use. See Ashe, 9
S.W.3d at 123. In making this determination, the jury could have considered ―the
plaintiff’s idiosyncrasies, fears, age, medical condition, and religious beliefs.‖ Id. at 124
(citing Fain v. Smith, 479 So. 2d 1150, 1155 (Ala. 1985); Bernard v. Char, 903 P.2d 667,
674 (Haw. 1995); Backlund v. Univ. of Wash., 975 P.2d 950 (Wash. 1999)). The jury
was also instructed to consider the presence or absence of alternative

                                            -12-
procedures/treatments, the potential risks and benefits of those procedures, and the
impact on Mr. White’s health if InFuse had not been used.8

       On these issues, the jury heard from a number of witnesses including Dr. Beeks
and his expert witness, Dr. Kauffman, and Mr. White and his expert witness, Dr. Law. In
his pretrial deposition, when asked what risks were associated with the use of InFuse, Dr.
Law stated,

                I’ve had one case of ectopic bone growth. I’ve had, oh, probably
        [ten] cases of a cystic lesion that forms behind the, in the patient’s spinal
        canal. It’s an inflammatory response. I’ve had probably a [fifteen] percent,
        [fifteen] to [twenty] percent inciden[ces] of patients developing
        inflammation postoperative – I would say, I would lump them all into
        [fifteen] to a [twenty] percent complication rate where patients either
        developed postoperative radiculitis or they developed a postoperative fluid
        collection where I had to take them back to surgery to draw the fluid off, or
        they have developed a cystic situation which I’ve actually had to take them
        back to surgery for.

        8
         Dr. Beeks requested the following special jury instruction, which was agreed upon by the parties
and provided to the jury:

                A physician has a duty to give a patient certain information before treating the
        patient; the information the physician must disclose is that information about the
        treatment involved and its attendant risks to enable the patient to make an intelligent
        decision about whether to undergo the treatment. The information that must be provided
        to the patient is that information that would be provided by physicians in the specialty in
        the community in which the physician practices or in similar communities.

                In this case, plaintiff has the burden of proving:

                    (1) What a reasonable medical practitioner in the same or similar
                    community would have disclosed to the patient about InFuse and
                    the risks of it;
                    (2) That the defendant departed from the standard; and
                    (3) That a reasonable patient in plaintiff’s position would have
                    refused the treatment with InFuse if properly advised of the
                    risks.

                In determining how a reasonable patient would have acted under the
        circumstances, you should consider the testimony of the plaintiff, the plaintiff’s
        idiosyncrasies, fears, age, medical condition, and religious beliefs, the presence or
        absence of alternative procedures/treatments and the potential risks and benefits thereof,
        and the impact of not using InFuse on plaintiff’s health.

                                                    -13-
At trial, however, Dr. Law was precluded from testifying about the risks of InFuse that
had not materialized. Consequently, he was not allowed to tell the jury about the risks of
cystic lesions, fluid collection, or any other risks associated with InFuse that did not
materialize. Thus, when asked at trial what risks were associated with InFuse, Dr. Law
stated only the following: ―[T]he main risk is inflammatory reactions, that can cause
continued nerve pain. It can cause nerve irritation[,] and also the ectopic bone growth
certainly is a complication that should be explained to the patient.‖

        After a careful review of the record, we hold that Mr. White was deprived of key
evidence that was critical to his ability to prove his informed consent claim. This was a
close case. The expert witnesses on behalf of Mr. White and Dr. Beeks offered differing
opinions as to whether Dr. Beeks disclosed to Mr. White adequate information about the
risks associated with spinal fusion surgery and the use of InFuse. Unlike Dr. Law,
however, Dr. Beeks and his expert, Dr. Kauffman, were not precluded from offering
substantial testimony against Mr. White’s informed consent claim. Had Dr. Law’s
testimony not been limited, the jury would have heard expert proof demonstrating that
Dr. Beeks failed to disclose to Mr. White that the use of InFuse was associated with a
number of risks, in addition to ectopic bone growth and inflammation, that not only might
have caused Mr. White continued back pain, but might have necessitated further invasive
procedures. Given the issues in dispute, this would have had a significant effect on the
jury’s determination of whether Dr. Beeks obtained Mr. White’s informed consent before
using InFuse and whether a prudent person in Mr. White’s position, adequately informed,
would have consented to its use. The effect of the trial court’s ruling was that the jury
did not have the opportunity to hear relevant, admissible evidence supporting Mr.
White’s informed consent claim. Cf. White v. Vanderbilt, 21 S.W.3d 215, 229-30 (Tenn.
Ct. App. 1999) (finding that the erroneous exclusion of an expert’s deposition was not
harmless, as it prevented the plaintiffs, in a close case, from introducing relevant
evidence to support their medical malpractice claim); Brown v. Daly, 968 S.W.2d 814,
817-18 (Tenn. Ct. App. 1997) (finding that the erroneous exclusion of a party’s proffered
statement on the basis that it was hearsay was not harmless, as exclusion of this testimony
prejudiced that party’s ability to refute the opposing party’s defense); Pankow v. Mitchell,
737 S.W.2d 293, 298 (Tenn. Ct. App. 1987) (finding that the erroneous exclusion of a
prior complaint filed by the plaintiff containing statements contradicting the plaintiff’s
trial testimony was not harmless, as the contradicting information contained in the
complaint was relevant to a contested, material issue at trial).

       We hold that the erroneous exclusion of Dr. Law’s testimony, more probably than
not, affected the outcome of the trial. See Smallman, 398 S.W.3d at 152. Accordingly,
the error was not harmless, and Mr. White is entitled to a new trial on his informed
consent claim.

                                            -14-
                                      Conclusion

       We hold that the trial court erred by excluding expert testimony regarding
undisclosed medical risks that had not materialized. This error, more probably than not,
affected the jury’s verdict. Therefore, the judgments of the trial court and the Court of
Appeals are reversed, and the case is remanded to the trial court for a new trial on the
issue of informed consent consistent with the holdings in this opinion. Costs of this
appeal are assessed to David A. Beeks, M.D., for which execution may issue if necessary.

                                         _________________________________
                                         SHARON G. LEE, CHIEF JUSTICE

                                          -15-