Colorado Case Law

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GORAB v. ZOOK, 943 P.2d 423 (Colo. 1997)
LAWRENCE N. GORAB, M.D., Petitioner,
v. DANIEL C. ZOOK, Respondent.
No. 96SC90
Supreme Court of Colorado.
June 30, 1997
Petition for Rehearing DENIED September 8, 1997

Certiorari to the Colorado Court of Appeals

JUDGMENT REVERSED
Page 424

Kennedy & Christopher, P.C., Elizabeth A. Starrs, John R.
Mann, Denver, Colorado, Attorneys for Petitioner.

Daniel C. Zook, Colorado Springs, Colorado, Pro se
Respondent.
Page 425

EN BANC

JUSTICE SCOTT delivered the Opinion of the Court.

[1] We granted certiorari to review the judgment of the court of
appeals in Zook v. Gorab, No. 93CA0886, slip op. (Colo.App.
Sept. 28, 1995) (not selected for official publication).[fn1] In
Zook v. Gorab, the court of appeals reversed the trial court's
ruling granting a directed verdict for a physician on a claim for
lack of informed consent in a medical malpractice action. Because
we conclude that the plaintiff did not produce sufficient
evidence by which a jury might conclude that the physician's
failure to inform fell below the medical community's standard of
care, we reverse the judgment of the court of appeals.

I.

[2] In May 1987, petitioner, Lawrence N. Gorab, M.D. (Dr.
Gorab), treated respondent, Daniel C. Zook (Mr. Zook), for
prostatitis, a condition caused by the inflammation of the
prostate gland. Dr. Gorab prescribed a sulfa antibiotic drug
known commercially as Septra, which cured Mr. Zook's condition
almost immediately. However, during the time he was taking the
drug, Mr. Zook experienced fevers, chills, fatigue, and muscle
aches. On June 1, 1987, several days after Mr. Zook stopped
taking the drug, he experienced a spell resembling a grand mal
seizure, which Mr. Zook alleges was caused by an adverse reaction
to Septra.

[3] The parties dispute certain facts in the case. For example,
Dr. Gorab testified that when he prescribed Septra for Mr. Zook's
prostatitis on the initial visit of May 15, 1987, he informed Mr.
Zook of the "usual risks and precautions" of the drug, including
the risk of fever, rash, headaches, nausea, kidney stones, and
hepatitis. In contrast, Mr. Zook denies that Dr. Gorab informed
him about any risks other than nausea and kidney stones. Both
courts below found and the parties agree, however, that Dr. Gorab
did not warn Mr. Zook about the possibility of seizures from the
use of Septra.

[4] In addition, there is conflicting testimony regarding when
Mr. Zook informed Dr. Gorab that he was experiencing adverse side
effects from the drug. Mr. Zook claims that he and/or his wife
told Dr. Gorab that he was experiencing flu-like symptoms some
time between his initial visit on May 15, 1987, and his second
visit on May 22. Mr. Zook further claims that he tried
unsuccessfully to contact Dr. Gorab on May 23, 24, or 25, and
that he told Dr. Gorab on May 26 that he had a body temperature
of 102 degrees.

[5] Dr. Gorab, on the other hand, claims that he noted a full
respiratory infection during Mr. Zook's initial visit on May 15
and that he did not have contact with either Mr. Zook or his wife
between May 15 and May 22. Additionally, Dr. Gorab asserts that
his examination of Mr. Zook on May 22 indicated that he was
handling the medication well and was not experiencing any adverse
reactions. Dr. Gorab also denied that Mr. Zook contacted him
between May 22 and May 25. Rather, Dr. Gorab claims that his
next contact with Mr. Zook was on May 26, when he indicated he
had various flu-like symptoms.

[6] Mr. Zook filed this medical malpractice action, claiming
that Dr. Gorab was negligent in failing to advise him to stop
taking Septra after he began having an adverse reaction. Mr.
Zook also argued at trial that Dr. Gorab had not properly
obtained his informed consent[fn2] before administering the
Septra because he had not informed Mr. Zook of the possibility of
seizures.[fn3] Mr. Zook's informed
Page 426
consent claim also alluded to
Dr. Gorab's failure to inform him of the possible risks of
continuing to take Septra after Dr. Gorab learned of Mr. Zook's
flu-like symptoms.

[7] At trial, Mr. Zook's expert witness, Stanley M. Phillips,
M.D. (Dr. Phillips), testified that, in his opinion, Dr. Gorab
had not met the requisite standard of care in his treatment of
Mr. Zook and was therefore negligent. However, Dr. Phillips did
not testify that Dr. Gorab was required under the relevant
standards of the medical community to inform Mr. Zook of the risk
of seizure before prescribing the drug. In contrast, Dr. Gorab's
expert witness, Richard Augspurger, M.D. (Dr. Augspurger),
testified that the risk of seizure from Septra was insubstantial
and, therefore, under the applicable standards of the medical
community, Dr. Gorab was not required to inform Mr. Zook of that
risk before prescribing the drug.[fn4]

[8] After the close of the evidence at trial, Dr. Gorab moved
for a directed verdict on the issue of informed consent, arguing
that Mr. Zook had failed to rebut the expert testimony that Dr.
Gorab had properly obtained Mr. Zook's informed consent before
prescribing Septra. The trial court directed a verdict for Dr.
Gorab on the informed consent claim, ruling that he had met the
necessary standard of care despite not disclosing the risk of
seizure before prescribing the medication. The court then
submitted the general negligence claim to the jury and the jury
returned a verdict in favor of Dr. Gorab.

[9] Mr. Zook appealed and the court of appeals reversed the
trial court's directed verdict. The court of appeals held that
the conflict between the parties' version of events relieved Mr.
Zook of his burden of presenting expert testimony to rebut Dr.
Gorab's evidence that, under the standards of the medical
community, he was not required to disclose the risk of seizure
associated with Septra. See Zook, slip op. at 4. Additionally,
the court of appeals determined that "the factual issues
concerning [Mr. Zook's] lack of informed consent claim were
inextricably interwoven with those concerning his negligence
claim." Id. The court therefore ordered a new trial for both
the informed consent claim and the negligence claim.

II.

[10] Dr. Gorab argues that the court of appeals erred in
reversing the directed verdict based on the informed consent
claim because Mr. Zook failed to meet his burden of rebuttal
under that claim. Moreover, Dr. Gorab asserts that, by so
holding, the court of appeals implicitly and erroneously
concluded that a physician has a continuous duty to inform a
patient of possible side effects during the administration of
medication. We agree.

A.

[11] In ruling on a motion for a directed verdict, a trial court
must view the evidence and inferences in the light most favorable
to the party against whom the motion is directed. See Bloskas v.
Murray, 646 P.2d 907, 912 (Colo. 1982). A motion for directed
verdict should not be granted unless the evidence compels the
conclusion that a reasonable factfinder could not disagree and
that no evidence or inference has been presented at trial upon
which a verdict against the moving
Page 427
party could be sustained. See
Fair v. Red Lion Inn, No. 95SC753, slip op. at 9-10 (Colo. June
30, 1997).

[12] Under our precedent, a general claim for negligence in
medical treatment arises when a physician's care falls below the
degree of knowledge, skill, and care used by other physicians
practicing the same specialty. See Bloskas, 646 P.2d at 914.
Colorado Jury Instruction 15:2 states that "[a] physician is
negligent when the physician does an act which a reasonably
careful physician would not do or fails to do an act which a
reasonably careful physician would do." CJI-Civ.3d 15:2. For
example, as pertinent here, a physician may be liable for
negligence if a particular medication is not discontinued after
the patient complains of adverse effects and the medical
community's standard of care would require that a physician
discontinue that treatment. See generally Bowman v. Songer,
820 P.2d 1110 (Colo. 1991); Melville v. Southward, 791 P.2d 383
(Colo. 1990).

[13] In contrast, a claim for negligence based on lack of
informed consent is a separate claim, based on the information
communicated by a physician to a patient before a particular
procedure or treatment is commenced. See, e.g., Bloskas,
646 P.2d at 912; Mallett v. Pirkey, 171 Colo. 271, 282, 466 P.2d 466,
471 (1970). Colorado Jury Instruction 15:15 provides that "[i]n
order for the plaintiff to recover from the defendant on [a]
claim of negligence based on lack of informed consent . . . the
defendant [must have] negligently failed to obtain the
plaintiff's informed consent before [the medical treatment]."
CJI-Civ.3d 15:15 (emphasis added). Similarly, Colorado Jury
Instruction 15:16 provides that "[b]efore a physician
[treats] . . . a patient, the physician must obtain the informed
consent, whether express or implied, from the patient."
CJI-Civ.3d 15:16 (emphasis added).

[14] Although it is unrealistic to require that a physician
advise his or her patient of all conceivable risks of a
particular procedure or treatment, see Stauffer v. Karabin,
30 Colo. App. 357, 363-64, 492 P.2d 862, 865 (1971), we have
recognized that where the risk is one that would be medically
significant to the patient's decision, and the risk is known or
ought to be known by the physician, then it is a "substantial"
risk and should be disclosed to the patient, see Bloskas,
646 P.2d at 913 & n. 6 (relying on Mallett, 171 Colo. at 282,
466 P.2d at 471). Further, the substantiality of a particular risk must
be determined on the basis of expert testimony. See id. at 914
("The precise scope of the physician's duty of disclosure is
determined on the basis of expert testimony demonstrating the
extent of information given by reasonably careful physicians
practicing the same specialty in the same or similar
community."); see also United Blood Servs. v. Quintana,
827 P.2d 509, 520 (Colo. 1992) ("Because in most cases of professional
negligence the applicable standard is not within the common
knowledge and experience of ordinary persons, the applicable
standard must be established by expert testimony.").

[15] A claim for lack of informed consent involves a series of
shifting burdens. First, the patient must establish a prima
facie case by demonstrating that he or she was uninformed at the
time of consent due to a failure to disclose by the physician.
See Martin v. Bralliar, 36 Colo. App. 254, 258, 540 P.2d 1118,
1120 (1975); see also Melville v. Southward, 791 P.2d 383, 387
(Colo. 1990). Once there is evidence that a patient was
uninformed because of nondisclosure, the burden then shifts to
the physician to go forward with expert testimony showing that
the nondisclosure conformed with community, or where appropriate,
national medical standards of care.[fn5] See Mallet, 171 Colo.
at
Page 428
282, 466 P.2d at 471; Martin, 36 Colo. App. at 256,
540 P.2d at 1120; Stauffer, 30 Colo. App. at 364, 492 P.2d at 865. This
burden refers to the burden of production or going forward with
evidence, rather than to the ultimate burden of proof.

[16] Finally, if the physician produces competent expert opinion
of compliance with the applicable medical standards, the burden
then shifts back to the patient to present evidence that the
physician's failure to inform fell below the medical community's
standard of care. See Mallett, 171 Colo. at 282,
466 P.2d at 471; Conrad v. Imatini, 724 P.2d 89, 92 (Colo.App. 1986). If
the patient is able to meet this burden and create a disputed
factual question, the claim for lack of informed consent should
go to the jury. See Bloskas, 646 P.2d at 912; Mallett,
171 Colo. at 282, 466 P.2d at 471. However, if there is no dispute, and
the court viewing the evidence in the light most favorable to the
party against whom the motion is directed can rule on the
question as a matter of law, a directed verdict is appropriate.
See Bloskas, 646 P.2d at 912; Conrad, 724 P.2d at 92.

B.

[17] Here, it is undisputed that, prior to prescribing Septra,
Dr. Gorab did not disclose to Mr. Zook the risk of seizure as an
adverse side effect. It is also undisputed that Mr. Zook
suffered a seizure, which he contends resulted from his use of
Septra. Mr. Zook therefore established a prima facie case of
lack of informed consent and the burden shifted to Dr. Gorab to
demonstrate that under the circumstances, his failure to warn
complied with applicable medical standards.

[18] Dr. Gorab met his burden by presenting the expert testimony
of Dr. Augspurger, who testified that seizures suffered as a
result of taking Septra are extremely rare and, as such, a
reasonable urologist would not need to inform patients of that
possibility. Thus, Dr. Augspurger testified that Dr. Gorab's
disclosure, which did not include a warning about seizures,
conformed sufficiently to the medical community's standard of
care.

[19] Under the burden shifting framework set forth above, Mr.
Zook was then required to rebut Dr. Augspurger's testimony with
expert testimony of his own, thereby creating a disputed factual
question for the jury to resolve. The record reveals, however,
that Mr. Zook failed to present any testimony from a medical
expert that the warning given by Dr. Gorab when he prescribed
Septra did not comport with the applicable standard of care in
the medical community. Although Mr. Zook's expert witness, Dr.
Phillips, testified that Septra is a commonly prescribed
antibiotic, he did not express any opinion that reasonable
physicians informed their patients that the administration of
Septra may result in seizures.

[20] Rather, Dr. Phillips testified that Dr. Gorab was negligent
in not recognizing Mr. Zook's flu-like symptoms and thus failed
to meet the appropriate medical standard when he did not
eventually remove Mr. Zook from the medication. That evidence,
however, creates a question of fact only as to Dr. Gorab's
general negligence, a claim which the trial court properly
submitted to the jury. Dr. Phillips stated that, in his opinion,
Dr. Gorab, after being informed that Mr. Zook was having an
adverse reaction to Septra, should have diagnosed his condition
as a drug reaction, stopped treatment with Septra and substituted
another drug, and brought him in for further examination and
tests. However, that testimony related only to Dr. Gorab's
duties and obligations during the course of treatment, and not to
his initial duty to disclose the possible risks and side effects
of treatment.

[21] As to the initial disclosure by Dr. Gorab, Dr. Phillips
testified only that it would have been "good medical practice" to
advise Mr. Zook of the possible side effects and risks of Septra.
He never explained, however, what those possible side effects and
risks are or
Page 429
how they differed, if at all, from the risks and
side effects noted by Dr. Gorab when he initially prescribed the
antibiotic. Importantly, Dr. Phillips did not testify about the
standards in the medical community, or Dr. Gorab's success or
failure in meeting those standards.

[22] The court of appeals correctly noted that Dr. Gorab's expert
testified that the standard of care did not require him to inform
Mr. Zook that a seizure was a possible reaction to the
medication. See Zook, slip op. at 3. The court was concerned,
however, that "this testimony was all predicated on [Dr. Gorab's]
version of the events. There was no expert testimony presented
by [Dr. Gorab] that was based on [Mr. Zook's] rendition of the
facts." Id. The court then quotes testimony from Dr. Phillips,
which it determines supports the conclusion that Mr. Zook
adequately addressed the applicable standard of care and Dr.
Gorab's failure to satisfy it.

[23] In our view, the court of appeals takes Dr. Phillips'
testimony out of context and misapplies it. For example, in
response to a general question regarding the standard of care
"with regard to the monitoring of drugs and watching for drug
reaction," and whether that standard differs from one medical
specialty to another, Dr. Phillips stated and the court of
appeals quotes the following:

[T]here are certain levels [of disclosure of
side effects] that are true for any physician
that prescribes prescriptions and drugs, and
it doesn't matter whether what specialist it
is or what state it is, including this
state. . . . the standard of careful
administration and monitoring apply to any
specialty, in any state.

[24] Zook, slip op. at 3.

[25] The bracketed material in the above quotation was
specifically added by the court of appeals and does not
accurately reflect the substance of Dr. Phillips' testimony. The
record reveals that Dr. Phillips was responding to general
questions regarding whether the standard of care in "the
monitoring of drugs and watching for drug reaction" varied among
specialties, which was directed towards Mr. Zook's negligence
claim and not his informed consent claim. Moreover, this portion
of the testimony was preliminary in nature and apparently
designed to qualify Dr. Phillips as an expert witness. Indeed,
at this stage of the testimony, there was no discussion
pertaining specifically to Dr. Gorab's actions in either
disclosing the side effects or monitoring Mr. Zook's drug
reactions.

[26] Similarly, the court of appeals improperly relies on Dr.
Phillips' subsequent testimony that "[i]f [Mr. Zook's] rendition
of the dates and the times and what he communicated to the doctor
are accurate, [Dr. Gorab's] response was not appropriate." Id.
Again, however, Dr. Phillips' testimony supported Mr. Zook's
negligence claim against Dr. Gorab based on his alleged failure
to monitor and respond to the continued administration of Septra.
This portion of Dr. Phillips' testimony did not address the
initial disclosure of risks and side effects made by Dr. Gorab
when prescribing the drug. Thus, the testimony on which the
court of appeals relies in support of its conclusion that "a
genuine issue of fact remains" is in no way related to Mr. Zook's
lack of informed consent claim.

[27] Our review of the record reveals that Dr. Phillips testified
in very general terms about Dr. Gorab's initial disclosure to Mr.
Zook. He testified:

I don't think that there was, at least based
on the medical reports or Mr. Zook's
testimony, much of a discussion in terms of
possible side effects, what to expect,
exactly why the drug was being taken, these
sorts of things, which I think are good and
necessary in talking with the patient, so the
patient knows what is happening and what to
expect.

[28] This testimony is too vague to satisfy Mr. Zook's burden of
rebutting Dr. Augspurger's very specific testimony that seizures
as a result of taking Septra are very rare and that, under the
applicable standards of care, Dr. Gorab was not required to warn
Mr. Zook.

[29] In our view, stating that there was not "much of a
discussion in terms of possible side effects" does not refute Dr.
Augspurger's testimony as to the applicable standards of care in
the medical community. Thus, Mr. Zook offered no expert opinion
on
Page 430
whether Dr. Gorab's failure to inform him of the possibility
of seizure or other side effects deviated from applicable
standards of the medical community. Rather, the substance of Dr.
Phillips' testimony was that Dr. Gorab was negligent in failing
to evaluate and treat Mr. Zook after he began experiencing
flu-like symptoms.

[30] As a result, there was no factual dispute as to the failure
to disclose and, on this record, the trial court could and did
determine as a matter of law that Dr. Gorab's initial warning to
Mr. Zook, which omitted warnings as to seizures, conformed to
applicable medical standards and was therefore reasonable. Thus,
we conclude that, viewing the evidence in the light most
favorable to Mr. Zook,[fn6] the trial court properly directed a
verdict in favor of Dr. Gorab and against Mr. Zook on the claim
for lack of informed consent.

C.

[31] In addition, to the extent that Mr. Zook argues[fn7] or the
court of appeals' opinion suggests a continuing duty to inform,
we reject that view. A claim for lack of informed consent is
based on the information communicated by a physician to a patient
before a particular procedure or treatment is commenced. See,
e.g., CJI-Civ. 15:15, 15:16; Bloskas, 646 P.2d at 912; Mallett,
171 Colo. at 282, 466 P.2d at 471. Thus, once informed consent
has been obtained prior to treatment, a physician is under no
duty to continue warning the patient of possible side effects
during the continuing course of that treatment.

[32] We do recognize, however, that where a new, previously
undisclosed, and substantial risk arises, there may be an
additional and independent duty to warn by the physician. For
example, Mr. Zook hypothesizes a situation in which a physician
prescribes a drug and later learns from the manufacturer of a new
and material danger in its use. Similarly, Mr. Zook presents a
hypothetical involving a physician who prescribes medication to a
woman who he later learns is pregnant. We agree that, in
situations such as these, a physician may have a duty to disclose
certain risks to the patient. However, that duty clearly is not
a previously existing one, but rather is a new duty based on
changed circumstances.

[33] Here, no such changed circumstances exist. Although Mr.
Zook developed flu-like symptoms, there was no reason, based on
the testimony presented in the record, for Dr. Gorab to advise
Mr. Zook at that time about the risk of seizure. Rather, Dr.
Gorab's actions during the course of Mr. Zook's treatment were
the basis of Mr. Zook's negligence claim and not part of the lack
of informed consent claim. Indeed, the doctrine of informed
consent was developed in connection with a patient's consent to
specific surgical procedures so as to avoid a physician's
liability for battery, making the doctrine ill-suited to a claim
based on the administration of medication over a course of time,
which is better suited to a claim based upon a negligence theory
of liability.

[34] Thus, the continued use of medication for which the
physician has already provided sufficient warnings, without any
significant change in circumstance which would cause a risk to
become substantial, is not a basis for a lack of informed consent
claim. Because there was no testimony presented here that the
nature of the risk of seizure from Septra changed or materially
increased while Mr. Zook was taking the medication, Dr. Gorab was
under no new duty to disclose. Mr. Zook's claim against Dr.
Gorab and the
Page 431
evidence presented in support effectively allege a
failure to diagnose properly, rather than a failure to disclose a
substantial risk. We therefore reject Mr. Zook's argument that
Dr. Gorab had a continuing duty to warn.

III.

[35] In sum, we conclude that the trial court properly entered a
directed verdict in favor of Dr. Gorab on the lack of informed
consent claim. Under the shifting burden framework, Dr. Gorab
satisfied his burden by presenting expert testimony that his
failure to disclose the risk of seizure from Septra, either at
the time it was prescribed or during the continuing course of
treatment, was reasonable under the standards of the medical
community. Mr. Zook, however, presented no expert testimony to
the contrary and, as such, no question of fact remained and a
directed verdict was appropriate.

[36] Accordingly, we reverse the judgment of the court of appeals
and remand to that court for reinstatement of the jury verdict.

[fn1] Our order granting certiorari raised the following issues:

(1) Whether the court of appeals erred in
reversing the trial court's directed verdict,
thereby holding that a physician has a
continuous duty to obtain informed consent
from a patient during the course of
administering medication; and

(2) Whether the court of appeals erred in holding
that reversal of the directed verdict on the
plaintiff's informed consent claim also
requires a new trial on the negligence
claim.

[fn2] Although Mr. Zook did not specifically include a claim for
lack of informed consent in either the complaint or the amended
complaint, the trial court nevertheless allowed him to pursue
this theory at trial.

[fn3] The basis for damages at trial was the seizures suffered by
Mr. Zook. The failure to warn claim is therefore necessarily
limited to Dr. Gorab's failure to warn of the possibility of
seizures. Mr. Zook now argues as a basis for his lack of
informed consent claim that Dr. Gorab failed to warn him about
the risk of hepatitis and other side effects. However, because
this claim is not based on the damages asserted at trial, we will
not address it. Our review of the lack of informed consent claim
is therefore limited to Dr. Gorab's failure to warn Mr. Zook of
the possibility of seizures.

[fn4] In response to a question whether the applicable standard
of care required that a physician advise a patient of the risk of
seizure, Dr. Augspurger testified that "I would not inform [a
patient] of the seizure, and have not in my 18 years of practice
of urology. I have never had or seen a patient who has a seizure
from that. That would be very rare to inform a patient about."

In addition, another expert medical witness, Mario Oliveira,
M.D., testified as follows:

The seizures were not produced by any medication.
That is extremely rare, something like 0.8 percent
in a study conducted in Boston of over 31,000
patients . . . and the studies conducted in 1977
showed that only 1.5 percent of the patients had
seizures following exposure to medication
. . . .

[fn5] As noted above, expert testimony in medical malpractice
actions is necessary to determine the standards of professional
care and competence which define the concept of reasonableness
appropriate to adjudication of such disputes. See Bloskas,
646 P.2d at 914; Greenway v. Gill, 660 P.2d 1305, 1307 (Colo.App.
1982). "This principle acknowledges the practical problems faced
by fact-finders in seeking to apply an objective test of
`reasonable conduct' to the sphere of medical activity."
Greenway, 660 P.2d at 1307.

However, in some contexts of medical malpractice actions,
expert testimony is not required. For example, a plaintiff
alleging lack of informed consent does not necessarily have to
present expert testimony to establish his or her claim. The duty
of care in such cases arises from the general principle of full
disclosure, which is a principle not peculiar to any one
profession. Id. Thus, in establishing a prima facie case, a
plaintiff need not present expert testimony, only demonstrate
that the physician failed to disclose information. In contrast,
expert medical testimony is necessary to establish the defense of
conformance with standards of professional practice or the
failure to meet such standards. Id.

[fn6] The court of appeals was concerned with the trial court's
statement that it did not review the motion for directed verdict
in the light most favorable to Mr. Zook. We conclude that based
on any rendition of the facts, and viewed in the light most
favorable to either Mr. Zook or Dr. Gorab, the failure to warn of
the risks of seizures when prescribing Septra was reasonable
because there was no expert testimony to the contrary. Thus, any
error by the trial court was harmless and is not dispositive
here.

[fn7] Mr. Zook's tendered jury instructions specifically referred
to Dr. Gorab's negligence in failing "to inform the plaintiff of
the risks and complications associated with the continued use of
Bactrim/Septra." Further, at oral argument before this court,
Mr. Zook answered affirmatively when asked if he was contending
that there was an informed consent claim that ran alongside the
negligence claim during the course of treatment.



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