Daley v. The Regents of the U. of Cal. CA1/5 ( 2024 )

Filed 10/17/24 Daley v. The Regents of the U. of Cal. CA1/5
NOT TO BE PUBLISHED IN OFFICIAL REPORTS
California Rules of Court, rule 8.1115(a), prohibits courts and parties from citing or relying on opinions not certified for
publication or ordered published, except as specified by rule 8.1115(b). This opinion has not been certified for publication or
ordered published for purposes of rule 8.1115.
IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA
FIRST APPELLATE DISTRICT
DIVISION FIVE
ALYCESUN DALEY, A165440
(San Francisco City & County
Plaintiff and Appellant, Super. Ct. No. CGC-15-544501)
v.
ORDER MODIFYING
THE REGENTS OF THE OPINION AND DENYING
UNIVERSITY OF CALIFORNIA et REHEARING
al., [NO CHANGE IN
JUDGMENT]
Defendants and Respondents.
BY THE COURT:
It is ordered that the opinion filed herein on September 25, 2024, be
modified as follows:
On page 24 of the opinion, at the end of the last sentence in Part II
that reads “Given the totality of the evidence, we find no reasonable
probability that Daley would have obtained a more favorable result if the
NIH Evidence had been admitted,” the following footnote 9 is added:
9 Daley argues that, “[i]f the Trial Court’s exclusion of NIH Study
evidence stands, human research participants are essentially deprived of the
protections in legal actions of the very protocols and safety oversight in place
for their protections.” ~(AOB 66)~ The harmless error question, however,
turns not on public policy but on whether it is reasonably probable that the
1
error affected the outcome of Daley’s case in particular. We conclude there is
no such probability. Moreover, Daley has not established that such a policy
has been abridged, given the similarities between the consent form that the
jury considered and the protocols and safety oversight Daley cites.
The modification effects no change in the judgment.
The petition for rehearing is denied.
Date: 10/17/24 ________Jackson___________, P. J.
2
Filed 9/25/24 Daley v. The Regents of the U. of Cal. CA1/5 (unmodified opinion)
NOT TO BE PUBLISHED IN OFFICIAL REPORTS
California Rules of Court, rule 8.1115(a), prohibits courts and parties from citing or relying on opinions not certified for
publication or ordered published, except as specified by rule 8.1115(b). This opinion has not been certified for publication or
ordered published for purposes of rule 8.1115.
IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA
FIRST APPELLATE DISTRICT
DIVISION FIVE
ALYCESUN DALEY,
Plaintiff and Appellant,
A165440
v.
THE REGENTS OF THE (San Francisco City & County
UNIVERSITY OF CALIFORNIA et Super. Ct. No. CGC-15-544501)
al.,
Defendants and Respondents.
Plaintiff and appellant Alycesun Daley, suffering from twin-twin
transfusion syndrome (TTTS), consented to participate in a study sponsored
by the National Institutes of Health (NIH). Under the auspices of the study,
defendants and respondents performed two surgeries on Daley, using a
treatment known as selective fetoscopic laser photocoagulation (SFLP). After
the surgeries, Daley’s twins died. Daley sued respondents, alleging that
(1) the NIH protocol for the SFLP surgery called for a percutaneous approach
and a four-millimeter trocar, rather than the laparotomy, hysterotomy, and
five-millimeter trocar used by respondents, and (2) because respondents’
procedure was substantially different than the one to which she consented,
respondents were liable for medical battery and intentional infliction of
emotional distress. A jury returned a verdict for respondents. Daley appeals,
contending the trial court erred in excluding evidence of the NIH protocol and
1
related material. Because Daley has not established reversible error, we will
affirm the judgment.
I. FACTS AND PROCEDURAL BACKGROUND
A. Daley’s Complaint
Daley filed a complaint alleging battery and intentional infliction of
emotional distress against defendants and respondents Diana Farmer, M.D.,
Hanmin Lee, M.D., Robert Ball, M.D., and their employer, The Regents of the
University of California.
Daley alleged that she agreed to participate in a NIH trial study that
compared treatments for TTTS. One of those treatments, SFLP, involved the
entry of a trocar (tube) percutaneously (through the skin), the passage of a
fetoscope through the trocar to provide visibility inside the uterus, and the
use of a laser to photocoagulate (seal) certain blood vessels. Respondents,
however, allegedly performed a “substantially different procedure” on her,
using an open laparotomy and open hysterotomy, in which the fetoscope was
inserted by cutting open Daley’s abdomen and exposing the uterus.
Respondents also used a trocar measuring five millimeters in diameter,
which was larger than the instrument required by the NIH protocol. Daley
alleged that respondents’ approach was the proximate cause of the death of
her twin fetuses.
B. Dismissal by the Trial Court and Reversal on Appeal
In October 2017, the trial court dismissed Daley’s claims on the ground
they were time-barred under Code of Civil Procedure section 335.1. Daley
appealed (No. A153501). We reversed, holding that the court erred in
concluding that the discovery rule did not apply to medical battery claims as
a matter of law. (Daley v. The Regents of the University of California (2019)
39 Cal.App.5th 595, 606–607.) In the unpublished portion of our opinion, we
2
ruled that Daley’s claim for intentional infliction of emotional distress could
also proceed.
C. Trial after Remand
Trial by jury involved two phases. In phase 1, the jury rejected
respondents’ statute of limitations defense. Phase 2, at issue here, addressed
liability, causation, and damages.
1. Respondents’ Motion in Limine to Exclude NIH Evidence
In June 2021, before phase 2 began, respondents served their “MIL
No. 4 [¶] Omnibus Motion in Limine to Exclude Evidence Regarding the NIH
Trial Proceedings and Documents.” (Capitalization and boldface omitted.)
The motion sought to exclude evidence regarding the NIH TTTS study
(NIH Evidence), primarily on the ground that the material was irrelevant to
Daley’s causes of action because (among other things) Daley had not seen the
material by the time of her surgery and it thus had no bearing on the nature
of the surgery to which she consented. In addition to seeking exclusion of the
NIH grant application, funding, income, and authorship credit, it sought to
exclude the following (as characterized by Daley): (1) the NIH working
protocol for the study (Protocol), which specifies that the surgery was to be
percutaneous and involve a four-millimeter trocar;1 (2) adverse event reports
concerning the surgeries performed on Daley, as well as a report of a protocol
deviation regarding the need for a second surgery; (3) Dr. Farmer’s and Dr.
Ball’s acknowledgement, after the death of the twins, that the use of larger
1 The Protocol stated: “Although almost all procedures can be
performed by a single percutaneous port, some cases with anterior placentas
may require a second port or even a laparotomy to expose the surface of the
uterus. We expect this to be necessary in fewer of 10% of cases. A 4-mm
incision is made in the skin to allow ultrasound-guided placement of a 4-mm
trocar into the amniotic cavity.” (Italics added.)
3
instruments and laparotomies at the University of California, San Francisco
(UCSF) was problematic; and (4) documentation that the NIH study was
paused and respondents were to obtain training and smaller instruments
before it would be resumed.
Daley opposed respondents’ motion, noting that respondents were
required to follow the NIH protocol and arguing the relevance and
importance of the evidence to her battery claim, causation, and the
outrageous nature of respondents’ conduct.
The trial court first heard respondents’ motion in December 2021. The
court permitted supplemental briefing, announced a tentative ruling that the
evidence was irrelevant, and held multiple hearings thereafter. At a hearing
on February 28, 2022, Daley’s counsel argued that Daley had surgery at
UCSF only because of the NIH study and believed there was a protocol
(presumably approved by NIH) that UCSF would follow.
By written order filed on March 3, 2022, the trial court granted
respondents’ motion, “subject to a further showing by [Daley] as to the
relevance and admissibility of any of the 181 NIH documents identified on
[Daley’s] Exhibit List.” The court ruled that “[t]he NIH documents are
irrelevant.” It also observed, for purposes of Evidence Code section 352, that
it had “weighed the probative value of the evidence against the admissibility”
and found that “the admission of the NIH documents would necessitate
undue consumption of time, create substantial danger of undue prejudice,
confuse the issues, and mislead the jury.” The court explained: “The only
documents [Daley] saw at the time of entering into the NIH study and at the
time of her procedures were (1) a pamphlet of information provided by the
University of Utah; (2) consent forms she signed when she enrolled in the
NIH study at the University of Utah; [and] (3) . . . the preoperative consent
4
forms signed at UCSF. [Daley] never read any other NIH documents, nor
was she aware of the content of any other NIH documents until after
contacting an attorney some 12 years after the events which form the
gravamen of this case. Accordingly, none of the remaining NIH documents
can form the basis of her claims for medical battery and intentional infliction
of emotional distress.” Thus, despite Daley’s argument that her consent form
had referred to the NIH study, the fact that Daley was unaware of the
Protocol until years after the surgeries meant it had “no relevance to what
[Daley] consented to or whether the procedures performed were substantially
different.”
After yet further briefing and additional hearings in March 2022, the
trial court maintained its view that the evidence was inadmissible, again
noting that Daley never read the Protocol and had no knowledge of it.
2. Trial Testimony and Evidence
a. Daley’s Condition and Possible Treatments
While pregnant in Utah, Daley was diagnosed with TTTS, a condition
that can arise when fetal twins share a placenta. In some cases, a connection
between the fetuses’ blood vessels on the placenta results in uneven blood
flow to the fetuses. Without treatment, nearly all such fetuses are lost.
One treatment for TTTS is amnioreduction, which removes fluid from
the amniotic sac of one of the fetuses. Another treatment is SFLP, which
uses a fetoscope, inserted in a trocar (tube) through the abdomen and into the
uterus, to enable a surgeon to seal selected blood vessels on the placenta with
a laser.
In discussions with physicians at the University of Utah, Daley learned
of the NIH study comparing amnioreduction and SFLP in the treatment of
TTTS. Hoping to save her twins, Daley agreed to participate in the study.
5
b. Daley’s NIH Consent Form
Daley signed a 12-page consent form entitled “A PROSPECTIVE
RANDOMIZED MULTICENTER TRIAL OF AMNIOREDUCTION vs.
SELECTIVE FETOSCOPIC LASER FOR THE TREATMENT OF TWIN-
TWIN TRANSFUSION SYDROME [¶] RESEARCH CONSENT FORM” in
Utah on July 28, 2003 (Consent Form).
The Consent Form explained that participants in the study would be
randomly placed in one of two groups—one group would receive
amnioreduction and the other would receive SFLP. The Consent Form
described amnioreduction as a procedure during which “a needle [is used] to
draw off fluid from the bag of water.” It described SFLP as “the use of a laser
beam to block or seal the vessels (photocoagulate) on the surface of the
placenta so that the twins can no longer share the vessels,” which is
performed “using an instrument inserted through the mother’s abdominal
wall into the amniotic sac called a fetoscope.”
The “Study Procedure” section of the Consent Form, under the heading
“Selective Fetoscopic Laser Procedure,” stated: “The procedure is performed
in the operating room at [UCSF]. The abdomen is sterilely cleaned and
draped . . . for an operation. A 4-mm (about 4 inches) incision is made in the
skin to allow ultrasound-guided placement of a 4-mm narrow tube into the
amniotic sac.” The Consent Form further stated: “In rare instances in which
we are unable to see the surface of the placenta, a [laparotomy] (opening of
the abdomen) to expose the uterus may be necessary,” usually because the
placenta prevents proper placement of the fetoscope. “Typically, the
procedure is performed through a [trocar] (narrow tube that is inserted into
the amniotic sac) through which a fetoscope is passed.”
6
The Consent Form included other disclosures, such as the risks and
benefits of the surgery and alternative procedures. It further made
numerous references to the NIH and advised that “[t]his study is sponsored
by the National Institutes of Health and expects to enroll at least 150 women
who have twin-twin transfusion syndrome.”
Kristi Nelson, the nurse who reviewed the Consent Form with Daley
when she signed it in Utah, testified that she would not have discussed with
Daley “technically how the procedure would be done . . . [i]n other words, how
the scope would make its way into the uterus.”
c. Assignment to UCSF for SFLP Treatment
Daley was assigned to the SFLP arm of the study and travelled to
UCSF for the procedure. At trial, she acknowledged that the only documents
she saw regarding the study were a brochure, the Consent Form, and UCSF
consent forms she received before her two surgeries (discussed below). None
of these documents identified a specific “protocol” for the procedure or
mentioned the word “percutaneous.”
At trial, Daley testified that she read the Consent Form thoroughly. It
led her to believe that the surgeons would follow a protocol (presumably
reviewed and approved by the NIH) and there was a 73 percent survival rate
for her twins. The Consent Form’s statement that Daley would give her
confidential information to the NIH made her feel it was a “government
contract” and there would be “checks” and “balances” and “committees.”
Because the Consent Form stated that all information regarding the
treatment would go to the NIH, she felt “safe” and “secure.” She trusted in
the study and the “institution” and believed she would get the surgery
described in the “NIH study form.” Her counsel asked on direct examination,
“Upon reading the consent form did you believe there would be protocols to be
7
followed at UCSF?” Daley answered: “I believe that they would follow
protocol.”
d. Daley’s First Surgery (Dr. Farmer)
Before the first surgery, Daley signed a UCSF consent form entitled
“Authorization for Surgery or Special Diagnostic Therapeutic Procedure.”
(Capitalization and boldface omitted.) The form did not describe any details
of the SFLP procedure.
Dr. Farmer, who was to perform the surgery, remembered discussing
the surgery with Daley in person, because Daley was from Utah and Farmer
hailed from Idaho, and it was unusual for Farmer to treat patients from
another state. Consistent with her general practice, Farmer described the
procedure to Daley in detail. Farmer testified: “I was very clear exactly how
I was going to make the incision, exactly what I was going to do with her,
that we were going to put in the scope and do a laser ablation. And that’s
exactly what we did.” Farmer recalled telling Daley that she would make an
incision, expose the uterus so they could insert the trocar, and insert the
fetoscope so they could see the vessels. At trial, Daley did not deny having a
conversation with Farmer, but she could not recall the specifics—just
generally that respondents were going to “go in” and cauterize the blood
vessels and that she was in good hands.
Dr. Ball testified that he had a “long discussion[]” with Daley before the
first surgery because it was his practice to confirm there was “no confusion
about what would be happening.” He addressed risks, benefits, and
alternatives to treatment, but due to his role as the maternal-fetal medicine
specialist, he focused more on preoperative and postoperative care than on
the surgery itself, which he likely discussed only in generalities. Daley
recalled a discussion with Dr. Ball but not its content.
8
Daley testified that, by the time of the surgery, she understood the
procedure would involve a cut in her abdomen and a hole or opening in her
uterus. At trial, she denied understanding that the surgeons would decide
how big a hole to make in her uterus, but respondents introduced deposition
testimony that she hoped they would use her best interest and the twins’ best
interest in deciding how big the hole needed to be.
Dr. Farmer performed the surgery. She made a small incision in the
abdomen wall that allowed her to see the surface of Daley’s uterus, where
Farmer wanted to place a trocar. Guided by ultrasound, she placed two stay
sutures in the outer layer of the uterus to provide counter traction. Then she
inserted the trocar through the uterine wall, using a type of trocar known as
a “radially-expanding device,” which enters with a diameter of about
three millimeters and expands after insertion to over five millimeters.
Farmer next inserted the fetoscope through the trocar to examine the
placenta. Using the fetoscope and ultrasound for guidance, Farmer identified
two blood vessels that were potentially connecting the fetuses and used a
laser to coagulate them. Farmer was unable to complete the procedure,
however, because blood in the amniotic fluid decreased visibility. Farmer
withdrew the instruments, sutured the hole in the uterus, and closed the
incision in the abdomen.
Dr. Farmer testified that she performed the procedure exactly as she
described it to Daley. She denied that the procedure was different or more
invasive than the procedure described in the Consent Form.2
2 After Daley testified to her belief that UCSF would follow a protocol
approved by NIH and Dr. Farmer testified as to what the Consent Form
required, Daley’s attorneys renewed their request that the Protocol be
admitted into evidence. Counsel argued: “I should further add that . . .
Daley testified that she believed there was a protocol that would be followed.
9
e. Daley’s Second Surgery (Dr. Lee)
Daley underwent a second (or “redo”) surgery on August 7, 2023.
Before this surgery, Daley signed another UCSF consent form similar to the
one she signed before the first surgery. She also spoke with Drs. Farmer and
Ball, similar to their discussions before the first surgery.
Performed by Dr. Lee, the second procedure was essentially the same
as the first procedure performed by Dr. Farmer. The second procedure was
successful.3
f. Daley’s Chorioamnionitis and Death of the Twins
Daley returned to Utah. Several weeks later, she developed E. coli
chorioamnionitis, resulting in preterm labor, rupture of membranes, and the
demise of both twins. Daley introduced evidence that the chorioamnionitis
was caused by the procedures performed at UCSF; respondents introduced
evidence that it was not.
g. Daley’s Expert (Dr. Quintero)
Daley presented expert witness testimony from Ruben Quintero, M.D.,
who had “basically” developed the field of operative fetoscopy—the ability to
treat fetuses in the womb with the use of a minimally invasive approach and
very small instruments. Quintero was the first to describe the proper
surgical technique, which was percutaneous—inserting the trocar through
the skin without having to open the abdomen—as opposed to performing a
And so if . . . Daley believes there is a protocol and Dr. Farmer wants to take
the position that the consent form is not precise enough, then we have very
good evidence to give to the jury about what was supposed to be done to her,
in the form of the protocol.” Throughout the trial, Daley continued to urge
the admissibility of the NIH evidence, to no avail.
3 Dr. Ball did not perform the first or second surgery.
He was in the
operating room in case Daley had a complication directly related to her
pregnancy or her own health.
10
laparotomy (an incision in the abdomen that allows the doctor to see inside
with the naked eye) and a hysterotomy (an incision in the uterus).
Dr. Quintero opined that respondents performed an “entirely different”
and more invasive procedure than what was described in the Consent Form,
and that respondents’ procedure caused the death of the twins. First, in Dr.
Quintero’s view, the Consent Form required a percutaneous approach, using
a small incision like a “nick,” which is less invasive than a laparotomy and
hysterotomy because it disturbs the uterus less and presents less risk of
bleeding. A laparotomy and hysterotomy entail large incisions, are not
described on the Consent Form, and resulted in moderately bloody amniotic
fluid. Second, respondents used a five-millimeter instrument—larger than
the four-millimeter instrument described in the Consent Form—which tears
the muscle and causes bleeding. Third, the procedure performed by
respondents takes longer than the percutaneous approach. Fourth,
respondents’ placement of stay sutures in the uterus at the trocar insertion
site was more invasive and provided another reason respondents’ procedure
was totally different.
Dr. Quintero admitted that puncturing the uterus with a four-
millimeter trocar (that was not radially expanding) can create a hole in the
uterus up to six or seven millimeters. Respondents’ counsel challenged
Quintero’s opinions about the cause of Daley’s chorioamnionitis, eliciting that
Quintero was not board certified and did not serve a residency or fellowship
in infectious disease or pathology. Quintero was unaware of any study
evaluating whether the use of a five-millimeter trocar rather than a four-
millimeter trocar increased the risk of chorioamnionitis.
11
h. Respondents’ Expert (Dr. Walker)
Respondents presented expert witness testimony from Martin Walker,
M.D., the co-director of the Maternal-Fetal Intervention and Surgery
Program at Seattle Children’s Hospital. Walker had performed nearly 600
SFLP procedures to treat TTTS.
Dr. Walker opined that the procedures Daley received were “no
different” than what was described in the Consent Form and “no more
invasive than [what] would have been discussed with her before surgery.”
Dr. Walker testified that the Consent Form broadly described the SFLP
procedure and included references to the risks of infection, bleeding,
membrane separation, and pregnancy loss. Walker opined that the use of the
radially expanding trocar did not increase the risk of membrane separation
or membrane rupture. When it penetrated the uterus, the radially expanding
trocar was smaller than four millimeters. Nor did the trocar increase the risk
of E. coli chorioamnionitis, which was the undisputed cause of Daley’s
preterm labor, premature rupture of membranes, and demise of the fetuses.
By stipulation of the parties, the jury was instructed that they had to
accept as true that “Daley was part of the NIH Trial during her procedures at
UCSF.”
3. Jury Verdict for Respondents
The jury returned a verdict for respondents on both causes of action.
On the battery claim, the jury found that respondents did not perform a
medical procedure without Daley’s consent or perform a procedure that was
substantially different than that to which Daley consented. On the
intentional infliction of emotional distress claim, the jury found that
12
respondents’ conduct was not outrageous. Judgment was entered for
respondents. Daley timely appealed.4
II. DISCUSSION
Daley contends the trial court erred by excluding the NIH Evidence on
the ground it was irrelevant to her claims under Evidence Code section 210
and inadmissible under Evidence Code section 352. We conclude that, even if
the court erred, the error was harmless.
A. Medical Battery
The jury was instructed, pursuant to CACI No. 530A, that the elements
of medical battery are (1) the defendant performed a medical procedure
without the patient’s consent, or the patient consented to one medical
procedure, but the defendant “performed a substantially different medical
procedure”; (2) the patient was harmed; and (3) the defendant’s conduct was
a substantial factor in causing the harm.5
As respondents emphasize, medical battery is distinguishable from
negligence, which Daley did not allege. Battery arises “[w]here a doctor
obtains consent of the patient to perform one type of treatment and
subsequently performs a substantially different treatment for which consent
was not obtained.” (Cobbs v. Grant (1972) 8 Cal.3d 229, 239 (Cobbs) [e.g.,
4 Respondents filed a cross-appeal but elected not to pursue it.
5 Daley’s other claim for intentional infliction of emotional distress
required proof of outrageous conduct. Daley argues that the excluded
evidence was relevant to show that respondents’ conduct was outrageous, in
that their lack of training and required instruments rendered the battery
inevitable. As alleged in the complaint, however, Daley’s claim for
intentional infliction of emotional distress was derivative of her battery
claim: if there was no non-consensual procedure, there was no outrageous
conduct. Accordingly, if there was no error in excluding the evidence as to
the battery claim, any error in excluding it as to the emotional distress claim
would be harmless. We therefore focus on the battery claim.
13
patient consents to an electromyogram but physician performs a myelogram,
patients consents to exploratory surgery but physician performs
mastectomy]; Kaplan v. Mamelak (2008) 162 Cal.App.4th 637, 646 [medical
battery claim stated where patient consented to surgery on T8-9 disk but
defendant performed surgery on T6-7 and T7-8 disks]; Ashcraft v. King (1991)
228 Cal.App.3d 604, 610–612 [because patient’s consent to blood transfusions
was limited by patient to family donors, surgeon’s transfusion of blood from
nonfamily donors was a battery].) By contrast, where a doctor obtains
consent to perform a treatment but does not disclose a potential complication
that was a known risk yet “not an integral part of the treatment procedure,”
the doctor’s failure to obtain informed consent sounds in negligence. (Cobbs,
at pp. 239, 240; Saxena v. Goffney (2008) 159 Cal.App.4th 316, 324; Daum v.
SpineCare Medical Group, Inc. (1997) 52 Cal.App.4th 1285, 1313.) And
where a doctor obtains consent to perform a treatment but performs it in a
substandard manner, the cause of action sounds in professional negligence.
(See So v. Shin (2013) 212 Cal.App.4th 652, 667.) Thus, for her battery
claim, the key for Daley was to prove that respondents’ procedure was
substantially different than what Daley consented to and caused the death of
her twins.
B. Relevance
Relevant evidence is “evidence, including evidence relevant to the
credibility of a witness or hearsay declarant, having any tendency in reason
to prove or disprove any disputed fact that is of consequence to the
determination of the action.” (Evid. Code, § 210.) The question for the trial
court, therefore, was whether the NIH Evidence tended to prove or disprove
what procedure Daley consented to, whether respondents’ procedure was
substantially different, or what caused the twins’ death.
14
As described above, relying on the fact that Daley did not know the
contents of the Protocol or other NIH Evidence until years after the surgery,
the trial court concluded that the evidence was irrelevant to Daley’s consent
and therefore irrelevant to whether the procedure performed by respondents
was substantially different than the one to which she agreed.
Daley complains that, in so ruling, the trial court erroneously employed
a “heightened standard” of relevance to her claims by limiting evidence of
consent to what Daley heard, observed, and understood before the surgeries.
What Daley describes, however, is not the court’s use of an incorrect
standard. Rather, the issue is whether the court abused its discretion in
applying the correct standard but concluding the evidence was irrelevant.
That said, we question the trial court’s ruling in at least one respect—
whether Daley made a sufficient showing of relevance for admission of the
NIH Protocol. The treatment to which Daley agreed was in the context of a
NIH study. The Consent Form repeatedly referred to the NIH’s sponsorship
and involvement, and the NIH’s involvement and oversight gave Daley a
sense of security and safety. Moreover, Daley’s attorneys made an offer of
proof—and Daley subsequently testified—that the Consent Form led her to
believe that UCSF (respondents) would “follow protocol.”6 Arguably, the
procedure to which Daley consented when signing the NIH Consent Form in
Utah was whatever procedure the NIH had reviewed and set up for the
surgery in the Protocol (whether she knew the specifics or not), and the mere
6 Indeed, section 8.1 of the Protocol states:
“The Principal Investigators
of the participating centers have agreed to abide by the study protocol, to have
comparable staff facilities and equipment, and to ensure the proper conduct of
the study at each center. Proper conduct of the study includes recruitment
and treatment of patients as specified in the protocol and accurate data
collection.” (Italics added.)
15
fact that the surgery was to be performed at UCSF gave Daley no reason to
think that respondents would part ways with those Protocol procedures.
Because the evidence was reasonably susceptible of that conclusion, the
Protocol was not irrelevant to the jury’s determination of the procedure to
which Daley consented and, ultimately, whether respondents provided a
substantially different procedure. (See Evid. Code, § 403.)
The cases on which respondents rely, and the trial court cited, do not
persuade us otherwise. (Daum v. SpineCare Medical Group, Inc., supra,52 Cal.App.4th at pp. 1311–1313; Suthers v. Amgen Inc. (S.D.N.Y. 2005)
372 F.Supp.2d 416, 425; Suthers v. Amgen Inc. (S.D.N.Y. 2006) 441 F.Supp.2d
478, 484; Freedman v. Superior Court (1989) 214 Cal.App.3d 734, 740, fn. 2.)
None of those cases involved the exclusion of evidence of a study protocol
where, as here, the patient testified that a consent form led her to believe the
surgeons would follow the protocol required by the study.7
Ultimately, however, we need not decide whether the trial court’s
exclusion of the Protocol (and the purported requirements of percutaneous
entry and a four-millimeter trocar) constituted an abuse of discretion. Nor
need we decide whether the court erred in excluding the other NIH Evidence,
such as evidence that Daley’s surgeries were recorded as adverse events, that
the second surgery was noted as a protocol deviation, that Dr. Lee believed
the loss of Daley’s twins was related to respondents’ surgeries, that
7 We must also question the trial court’s ruling under Evidence Code
section 352, which gives the court discretion to “exclude evidence if its
probative value is substantially outweighed by the probability that its
admission” would lead to the consumption of undue time or create a
“substantial danger of undue prejudice, of confusing the issues, or of
misleading the jury.” If the court did not adequately discern the relevance of
the Protocol, it could not have adequately weighed its probative value.
16
respondents were assigned to additional training and acknowledged that use
of laparotomies and larger instruments posed a problem, that the study was
paused due to respondents’ procedures, and that the death rate of babies and
mothers purportedly suggested respondents’ procedures caused the demise of
Daley’s twins. As discussed next, if such error occurred, it was harmless
under the circumstances of this case.
C. Harmless Error
Daley cannot obtain reversal of the judgment unless she shows a
reasonable probability that she would have obtained a different result if the
NIH Evidence had been admitted. (Kline v. Zimmer, Inc. (2022)
79 Cal.App.5th 123, 134; Evid. Code, § 354; see People v. Watson (1956)
46 Cal.2d 818, 836.) She fails to do so.
Daley broadly urges that the trial court’s error “made it impossible for
. . . Daley to prove her claims.” (Boldface omitted.) To the contrary, Daley
presented the essential theory of her case through her own testimony and
through her expert witness, Dr. Quintero. Dr. Quintero opined at length that
respondents’ procedure was “entirely different” than the procedure he
instituted for SFLP and what the Consent Form required. He pointed out
that the surgery calls for percutaneous entry and the Consent Form described
an incision of just four-millimeters, but respondents instead “opened the
abdomen.” He noted that the Consent Form says a four-millimeter
instrument would be used, but respondents used a device that expanded to
five millimeters. He provided multiple reasons that respondents’ procedure
was more invasive than the procedure for SFLP contemplated by the NIH
study and opined it caused the fetal deaths.
Daley counters, however, that Dr. Quintero “was unable to show with
reference to the Protocol itself, that the surgery the UCSF Researchers were
17
required to perform, was percutaneous.” In other words, it was one thing for
Dr. Quintero to testify that the Consent Form required a certain procedure,
which respondents could rebut; it would have been different if Dr. Quintero
could have pointed to the Protocol to establish that percutaneous surgery
was, in fact, required. As such, Daley urges that respondents’ witnesses
escaped vital cross-examination and Dr. Quintero “had to endure defense
cross-examination with one arm tied behind his back.”
We appreciate the distinction Daley draws (and respondents ignore).
Nevertheless, we conclude that the excluded NIH Evidence would have made
little difference in light of the other evidence at trial.
First, although Daley testified that she thought a “protocol” would be
followed, the jury was not required to believe her. If Daley was not found
credible on this point, any link between the Protocol and the scope of her
consent would vanish, and the terms of the Protocol would have made no
difference in the outcome.
Second, even if the jury did believe that Daley thought a protocol would
be followed, and that she consented only to the procedure the Protocol
described, there is still no reasonable probability that the admission of the
Protocol would have tipped the scales in Daley’s favor. Fundamentally, the
Protocol and the Consent Form were essentially the same with respect to the
key issues of the size of the incision and trocar and the use of a laparotomy.
Both documents referred to a four-millimeter incision to be made into the
skin for insertion of a four-millimeter trocar. As to laparotomies, the Consent
Form stated that, “In rare instances in which we are unable to see the
surface of the placenta, a laparotomy (opening of the abdomen) to expose the
uterus may be necessary,” usually because “the placenta is on the front
surface of the uterus.” Conveying the same idea, the Protocol stated that less
18
than 10 percent of the time, “some cases with anterior placentas may require
a second port or even a laparotomy to expose the surface of the uterus.”
Because the Consent Form was nearly identical to the Protocol on these
points, there is no reason to believe that Daley would have fared better if the
Protocol had been admitted into evidence.
It is true that the Protocol affirmatively stated that “almost all
procedures can be performed . . . percutaneous[ly]” and the Consent Form did
not. The question in this case, however, was not whether the doctors were to
perform the SFLP procedure percutaneously in most instances, but the more
specific question of whether the laparotomy (and hysterotomy) performed on
Daley was substantially different than the procedure to which she consented,
where her consent recognized the possibility of a laparotomy in some
circumstances. As to those circumstances—and thus the breadth and
conditions of her consent—the Consent Form and Protocol were virtually
identical, and there is no reasonable probability that the presence or absence
of the word “percutaneous” affected the jury’s verdict here.
Furthermore, to the extent Daley believes it would have been helpful to
establish that the procedure was typically percutaneous, the admission of the
Protocol would not have been as compelling as she suggests. For example,
assuming Daley had been allowed to introduce the Protocol to try to show
that a percutaneous (puncture) approach was necessary, the cited portion of
the Protocol does not literally state that percutaneous entry was required, but
that “almost all procedures can be performed by a single percutaneous port.”
(Italics added.) Again, the Protocol expressly stated that “some cases with
anterior placentas may require a second port or even a laparotomy to expose
the surface of the uterus.” (Italics added.) Thus, the Protocol contemplated
the possibility of a laparotomy like the one performed by respondents. That
19
Daley did not have an anterior placenta does not change the fact that Daley,
by agreeing to the Protocol, necessarily consented to the possibility of a
laparotomy.
Further still, even if the Protocol were construed to require
percutaneous entry, Daley agreed in the Consent Form to a “4-mm (about 4
inches) incision.” (Italics added.) Thus, she understood that a “cut” would be
made in her abdomen. Dr. Farmer testified that she told Daley that she
would make an incision, expose the uterus so they could insert the
trocar, and insert the fetoscope so they could see the blood vessels.
Daley did not deny having this conversation and generally recalled that
respondents were going to “go in” and cauterize the blood vessels. In
fact, the jury heard Daley’s deposition testimony that she knew the surgeons
would decide the size of the opening in her uterus based on what they
considered her best interests. Similarly, even if Daley had been allowed to
introduce the Protocol to show that respondents were required to use a four-
millimeter trocar, the evidence established that a five-millimeter expanding
trocar was not substantially different: at the insertion point, the five-
millimeter trocar actually has a diameter of just three millimeters. In short,
even with the Protocol in evidence, there is no reasonable probability the jury
would have found that Daley received a substantially different treatment
than the one to which she consented.
Nor would the NIH Evidence have destroyed respondents’ credibility.
Daley argues that Dr. Farmer “offered testimony dancing around the size of
the trocar that was supposed to be used, which . . . Daley was unable to show
was not credible by bringing to bear the excluded NIH Study evidence.” But
the testimony Daley cites is this: “Q: It says here the size is referenced as 4
millimeters, right? [¶] A: I’m not sure, 4 millimeters—what of the piece of
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the instrument the 4 millimeters refers to here. But, yes, that is correct.
[¶] Q: And we agree that you used an instrument that was 5 millimeters,
correct? [¶] A: That the final size of the expanding device was 5
millimeters, yes.” (Italics added.) There was no dancing. Farmer agreed
with counsel as to what the Consent Form said and what instrument she
used.
Daley argues that respondents “used the exclusion of the NIH Study
materials to bolster their own pedigree/prestige in front of the jury by
pointing to their experience, when . . . Daley was left unable to push-back
that [respondents], in fact, lacked the training necessary to perform the NIH
Study procedure, and were required to go to Germany to receive training.”
Daley similarly argues that she “could have easily shown, with the excluded
NIH Study evidence, that [respondents] lacked the training to perform the
NIH Study surgery they agreed to provide, and . . . Daley agreed to receive,
under the Study protocol.” The documents to which Daley refers are
minutes of a meeting regarding the NIH trial, in which additional training
was recommended for two surgeons from each NIH trial site, and other
documents confirming completion of the training by Dr. Lee and Dr. Ball.
However, the material indicates that researchers from across the entire NIH
trial were to observe procedures in Germany, not that respondents were
called out for lacking the training needed to perform SFLP. Moreover, even
a mandate for additional training would not mean that the treatment Daley
received was substantially different than the treatment to which she
consented. (See also Evid. Code, § 1151 [evidence of subsequent remedial
measures “inadmissible to provide negligence or culpable conduct in
connection with the event”].)
21
Daley further argues that respondents “utilized the exclusion of the
NIH Study documents, which make abundantly clear that the second
surgery that was performed on . . . Daley was a part of the Study, to make it
seem as though it was not governed by the Study.” But Daley did not need
the NIH Evidence to show that the second procedure was governed by the
NIH study, because the parties stipulated—and the jury was instructed—
that it had to accept as true that “the parties agree that . . . Daley was part
of the NIH study during her procedures at UCSF.” The exclusion of the
evidence cannot be prejudicial for the reason articulated in Daley’s
argument.
Daley next contends the evidence would have shown “that the use of
the larger instrument at UCSF was not only improper, but acknowledged as
problematic.” The documents Daley cites—the study steering meeting
minutes of August 16, 2004—state that “the diameter of the endoscope used
in San Francisco was larger than that used in Philadelphia” and “Drs.
Harrison, Farmer and Ball recognized this as a problem and have corrected
their approach to perform the laser therapy by using the percutaneous
technique.” The doctors’ acknowledgement of a problem does not show what
Daley consented to or whether respondents’ procedure was substantially
different. To the contrary, the document states that the National Institute of
Child Health and Human Development decided the data gathered at UCSF
“should be analyzed and not excluded,” perhaps suggesting that the
procedures at UCSF were not substantially different than the procedures
required by the Protocol. And to the extent the evidence was relevant to
22
causation, any error in its exclusion was harmless, because the jury rejected
Daley’s claims on other grounds.8
Lastly, Daley contends the NIH Evidence would have shown that the
surgeries were recorded as adverse events and a protocol deviation. The
essence of the cited documents is that the first surgery could not be
completed because bleeding impaired visibility and a second procedure thus
became necessary. The evidence was cumulative to the testimony of Daley’s
expert and did little if anything to show that respondents’ procedure was
substantially different than what Daley agreed to.
In the end, Daley consented to “selective” “fetoscopic” “laser
photocoagulation,” and it is undisputed that she received a treatment that
was “selective,” was “fetoscopic,” and involved “laser photocoagulation.” She
agreed in the Consent Form to a “4-mm (about 4 inches) incision” to allow
entry of a four-millimeter fetoscope through the abdominal wall and into the
amniotic sac, as well as the use of a laser to seal blood vessels on her
placenta, and there is no evidence she received something substantially
different. (Italics added.) Although the Protocol called for a four-millimeter
trocar, respondents’ five-millimeter expanding trocar was even smaller than
that at the insertion point. Although the Protocol arguably called for
percutaneous entry, Daley knew that the surgery would involve a cut in her
abdomen and a hole in her uterus, and she understood that the surgeons
would decide how big the openings should be. Daley was further advised of
the possibility of a laparotomy. Although (consistent with the Protocol) the
8 Statements by Dr. Lee purportedly linking respondents’ procedures to
the death of the twins, if competent testimony, may have been relevant to
causation. But the jury did not reach the special verdict questions on
causation, rejecting Daley’s claim on other grounds. Any erroneous exclusion
of causation evidence was therefore harmless.
23
Consent Form stated that laparotomy would be reserved for “rare instances”
in which the surgeons cannot see the placenta surface, there was evidence
that she knew her abdomen and uterus would be opened, and thus knew a
laparotomy (opening of the abdomen) and hysterotomy (opening of the
uterus) could occur. While Daley may have received a procedure that was on
some points different than what was described in the Protocol, and perhaps
not up to the standards of the Protocol, the excluded NIH Evidence did not
show that Daley received a substantially different treatment as required for
medical battery. Given the totality of the evidence, we find no reasonable
probability that Daley would have obtained a more favorable result if the
NIH Evidence had been admitted.
III. DISPOSITION
The judgment is affirmed.
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CHOU, J.
WE CONCUR:
JACKSON, P. J.
BURNS, J.
A165440
Daley v. Regents of the University of California
25