Josette Taylor, Estate Of Fred E Taylor, V Intuitive Surgical Inc.

FILED
CURT OP ,4PPEALS
IN THE COURT OF APPEALS OF THE STATE OF WASHINGTON IS MIN Ii
DIVISION II 2015 JUL - 7 AM 8: 41
S
JOSETTE TAYLOR, as Personal No. 45052 -6 -II
representative of the Estate of FRED E. a
TAYLOR, deceased; and on behalf of the Estate
of FRED E. TAYLOR; and JOSETTE
TAYLOR, Individually,
Appellant,
V.
INTUITIVE SURGICAL, INC., a foreign PUBLISHED IN PART OPINION
corporation doing business in Washington,
MELNICK, J. — Josette Taylor, individually and in her capacity as the personal
representative of the estate of her husband Fred E. Taylor,' appeals from a jury verdict finding no
liability by Intuitive Surgical, Inc. ( ISI) under the Washington Tort Reform and Product Liability
Act ( WPLA),2 for Taylor' s injuries resulting from complications during a robotically assisted
prostatectomy. 3 Taylor argues that the trial court erred by not instructing the jury that ( 1) ISI,
manufacturer of the system used to perform the surgery, owed a duty to warn the hospital in
addition to the surgeon, and ( 2) strict liability governed the duty to warn. In the published portion
of this opinion, we hold that under the learned intermediary doctrine, ISI only had a duty to warn
Josette Taylor was not involved in the events at issue. For the purpose of simplicity, we refer to
the appellants collectively as " Taylor," and we will refer to Fred Taylor individually as the same.
We intend no disrespect.
2 Chapter 7. 72 RCW.
3 is
A prostatectomy is surgery in.which the
a patient' s prostate gland removed.
45052 -6 -II
the surgeon and not the hospital. We further hold that a negligence standard governs the duty to
warn a learned intermediary about a medical product.
Taylor further argues that the trial court abused its discretion by refusing to allow Taylor
to introduce evidence of other incidents concerning ISI' s product. In the unpublished portion of
this opinion, we hold that the trial court did not abuse its discretion by excluding Taylor' s evidence
of other incidents with ISI' s product. Accordingly, we affirm the trial court.4
FACTS
I. BACKGROUND
ISI designs, manufactures, and markets the da Vinci System. The da Vinci System
facilitates minimally invasive robotic surgery by allowing a surgeon to remotely operate very small
instruments that are inserted inside the patient' s body through incisions much smaller than those
used in traditional ( patient)
open - surgery. The use of small incisions often results in shorter
hospital A robotic surgery may not,
recovery times, fewer complications, and reduced costs.
however, remove as much cancer as an equivalent open procedure.
Despite these shortcomings,
the da Vinci System is now used in approximately 84 percent of prostatectomy surgeries in the
United States.
The da Vinci System is a fairly new technology, having been used for the first time on
humans in 1997. In 2001, the Food and Drug Administration (FDA) cleared ISI to market the da
4 Taylor requests that we reach two additional assignments of error: challenges to the trial court
failure to mitigate. Taylor concedes that the
instructing the jury on superseding cause and
challenged instructions do not constitute reversible error because the jury did not reach either issue.
However, Taylor requests that if we reverse the trial court and remand for a new trial, we address
the additional instructional challenges to avoid repetition of the trial court' s alleged errors on
remand. Because we affirm the trial court, we do not reach Taylor' s additional assignments of
error.
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Vinci System for prostatectomy surgery, finding that the da Vinci System was " substantially
equivalent" to devices that the FDA had cleared in the past.5 Clerk' s Papers ( CP) at 344; see
Federal Food, Drug, and Cosmetic Act, § 510( k), 21 U.S. C. § 360( k). The da Vinci System is
restricted " to sale by or on the order of a physician." CP at 364.
The da Vinci System is a highly complex medical device. While the learning curve varies
from surgeon to surgeon, ISI estimates that between 20 and 30 da Vinci System surgeries are
needed before a surgeon will be comfortable with the system. Although ISI' s learning curve
estimation is consistent with some scholarly research, other researchers believe that "[ s] urgeon
comfort and confidence" is not attained until a surgeon has performed between 150 and 250 robotic
procedures. Report of Proceedings ( RP) ( May 1, 2013) at 1948.
As part of their training, ISI requires surgeons who are just beginning with the da Vinci
System to undergo either two proctored cases or an amount set by hospital protocol. Following
that, ISI requires surgeons to choose simple cases for their first four to six unproctored procedures
and to " slowly progress in case complexity." Supp. CP at 6029. During their first surgeries with
the da Vinci System, surgeons performing prostatectomies are advised to choose patients with a
index ( BMI) less than 30 and no prior history of lower abdominal surgery. ISI
body mass of
specifically warns surgeons not to use the da Vinci System if a patient exhibits " morbid obesity."
CP at 159. Furthermore, ISI recommends that da Vinci System operators place their patients in a
steep Trendelenburg position, which means an incline of greater than 20 degrees. This position is
recommended to make it easier for the surgeon to see what he or she is doing.
Before a doctor may perform a procedure at a hospital or medical institution, he or she
must be credentialed by the institution. Each institution determines its own credentialing process.
5 The training program for new operators of the da Vinci System is not FDA approved.
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ISI recommends to hospitals that surgeons credentialed to use the da Vinci System " meet basic
and advanced laparoscopic requirements."' CP at 5798.
11. TAYLOR' S SURGERY
Dr. Scott Bildsten, who performed Taylor' s surgery, took an early interest in the da Vinci
System. At the time of Taylor' s surgery, Dr. Bildsten had extensive experience in traditional open
surgery and had performed between 80 and 100 open prostatectomies. He also had experience in
performing hand -assisted laparoscopic procedures, meaning he operated with one hand outside of
the patient' s body.
Dr. Bildsten received training from ISI and Harrison Medical Center credentialed him in
operating the da Vinci System. As part of his training, Dr. Bildsten observed more than ten
surgeries involving the da Vinci System, and he performed two proctored surgeries using the da
Vinci System. Although the proctored surgeries were " fairly long," Dr. Bildsten thought he had
done " really well" and felt encouraged to continue using the da Vinci System. RP (Apr. 23, 2013)
at 1067, 1071. Dr. Bildsten denied that ISI ever pressured him into performing robotic surgery.
In 2008, Dr. Bildsten treated Taylor for prostate cancer. They discussed various courses
of treatment, but Taylor insisted on a prostatectomy. They also discussed the possibility of a
robotic procedure, and Dr. Bildsten advised Taylor that he was " just starting with the robotic
technique." RP ( Apr. 23, 2013) at 1067. Taylor agreed to start with a robotic surgery and to
convert to an open procedure in the event of "any potential unsafe situations." RP ( Apr. 23, 2013)
at 1067.
6 A laparoscopic procedure is any procedure in which the surgeon inserts tools through .small
incisions.
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By Dr. Bildsten' s own admission, because of Taylor' s morbid obesity, 7 he was not an
optimal candidate for a prostatectomy. Dr. Bildsten understood that he should only operate on thin
patients while he was still new to the da Vinci System. Taylor had received numerous surgeries
in the past, including three abdominal surgeries. He also suffered from " uncontrolled" diabetes,
coronary artery disease, hypertension, and high cholesterol. RP ( Apr. 24, 2013) at 1346. Doctors
prescribed cholesterol medications for Taylor, but he did not consistently take them.
Nevertheless, in his first non -proctored surgery with the Da Vinci system, Dr. Bildsten
operated on Taylor. Dr. Bildsten could not put Taylor in the steep Trendelenburg position because
of Taylor' s" abdominal girth." CP at 253. As a result, Dr. Bildsten had no choice but to flatten
out Taylor to a slighter incline, which made it difficult to see what he was doing " due to the
field." CP 253. After " several hours of
continually getting into the
intestinal contents visual at
trying to get better visualization," Dr. Bildsten gave up on the da Vinci System and converted the
procedure to an open prostatectomy. CP at 253. At some point during the open procedure, Dr.
Bildsten tore Taylor' s rectal wall with his finger. Fecal matter escaped Taylor' s rectum and caused
a blood infection.
Taylor remained in the operating room for approximately 15 hours. He suffered various
complications from being under anesthesia for too long. He experienced a massive breakdown of
muscle and kidney failure because he was not moving and his blood was not circulating properly.
He also experienced brain swelling because his head was tilted down for an extended time during
surgery.
I
Taylor weighed 280 pounds and had a BMI of approximately 39. ISI advises beginner da Vinci
System operators to choose patients with a BMI of less than 30.
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the surgery, Taylor 20 days in the intensive care unit. He needed a
Following spent
him breathe for this time. Taylor had nerve and muscle
mechanical ventilator to help much of
damage, which may have been his stay in the intensive care unit. He also
caused by protracted
suffered a stroke during his stay in the intensive care unit.
III. AFTERMATH
Taylor' s quality of life diminished following his prostatectomy. He suffered weakness in
his shoulders, back, hip, and left arm; an atrophied right thigh; incontinence; and cognitive deficits
memory, depression, and He needed a cane to walk most of the time.
including poor anxiety.
Losing his independence caused Taylor a great deal of frustration.
Taylor died in 2012, four years after his prostatectomy. The cause of death was preexisting
hypertensive cardiovascular disease." RP ( May 6, 2013) at 2200- 01. The parties dispute whether
the prostatectomy hastened Taylor' s death.
PROCEDURAL HISTORY
Based on various legal theories, Taylor sued Dr. Bildsten, Dr. Bildsten' s partner and
medical practice, Harrison Medical Center, and ISI. In an amended complaint, Taylor dropped
Harrison Medical Center as a defendant. Taylor also settled with the doctors and their medical
practice, leaving ISI as the only defendant for trial. The trial court granted ISI' s summary
judgment motion on all of Taylor' s claims, except for the WPLA claim. Taylor does not assign
error on appeal to this order granting summary judgment and dismissal.
At trial, Taylor proposed jury instructions stating that ISI had a duty to warn not only Dr.
Bildsten, but also Harrison Medical Center. The trial court declined to do so and instructed the
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jury that ISI' s duty to adequately warn ran solely to Dr. Bildsten.8 Furthermore, the trial court
instructed the jury to apply a negligence standard in deciding ISI' s liability for failure to adequately
warn Dr. Bildsten. Taylor objected.
The jury returned a verdict in favor of ISI, with 10 of the 12 jurors concluding that ISI was
not negligent in warning and training Dr. Bildsten. Taylor appeals.
ANALYSIS
I. STANDARD OF REVIEW
We review a jury instruction de novo if the challenge is based on a matter of law, or for
abuse of discretion if based on a matter of fact. Kappelman v. Lutz, 167 Wash. 2d 1, 6, 217 P.3d 286
2009). "` Jury instructions are sufficient if they allow the parties to argue their theories of the
case, do not mislead the jury and, when taken as a whole, properly inform the jury of the law to be
825 ( 2005) ( quoting Hue v.
applied."' Joyce v. Dep' t of Corr., 155 Wash. 2d 306, 323, 119 P. 3d
Farmboy Spray Co., 127 Wash. 2d 67, 92, 896 P.2d 682 ( 1995)). Even if erroneous, a jury instruction
party. Anfinson FedEx Ground Package Sys., Inc., 174
is reversible error only if it prejudices a v.
Wn.2d 851, 860, 281 P.3d 289 ( 2012).
II. LEARNED INTERMEDIARY DOCTRINE
This case concerns the scope of a medical device manufacturer' s duty to provide adequate
warnings. In Washington, our learned intermediary doctrine treats manufacturers of prescription -
from of other products. McKee v. Am. Home
only medical products differently manufacturers
Products, 113 Wash. 2d 701, 709, 782 P.2d 1045 ( 1989); Terhune v. A. H. Robins Co., 90
Corp.,
Wn.2d 9, 12- 13, 577 P.2d 975 ( 1978). The learned intermediary doctrine affects who must receive
8 The court instructed the jury that a medical device manufacture' s duty is to adequately warn or
instruct/train the patient' s doctor. For simplicity, we refer to the manufacture' s duty simply as the
duty to warn.
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the manufacturer' s and how the adequacy of the warning is to be measured. See Ruiz -
warning
Guzman v. Amvac Chem. Corp., 141 Wash. 2d 493, 506- 08, 7 P.3d 795 ( 2000); Rogers v. Miles Labs.,
Inc., 116 Wash. 2d 195, 197, 207, 802 P.2d 1346 ( 1991); Terhune, 90 Wash. 2d at 12- 13; McKee, 113
Wash. 2d at 709, 711. The doctor acts as a gatekeeper between the manufacturer and the patient. See
Terhune, 90 Wi. 2d at 14; McKee, 113 Wash. 2d at 711. Therefore, both the challenged " failure -to -
warn instruction" and the challenged " negligence instruction" involve the same issue: whether the
learned intermediary doctrine is applicable in this situation.
In the following analysis, we explain the learned intermediary doctrine and its underlying
policy rationale. We then apply the learned intermediary doctrine to the facts of this case and
reject Taylor' s challenges to the " failure -to -warn instruction" and the " negligence instruction."
A. WPLA Duty to Warn
The WPLA preempts common law and governs all claims for product -related harm in
Washington. Wash. Water Power Co. v. Graybar Elec. Co., 112 Wash. 2d 847, 851, 853, - 856, 774
P.2d 1199, 779 P.2d 697 ( 1989); see RCW 7. 72. 010( 4). Under the WPLA, a product manufacturer
is liable if a claimant' s harm is " proximately caused by the negligence of the manufacturer in that
the product was not reasonably safe as designed or not reasonably safe because adequate warnings
or instructions were not provided." RCW 7. 72. 030( 1). Warnings or instructions are inadequate
if.
at the time of manufacture, the likelihood that the product would cause the
claimant' s harm.or similar harms, and the seriousness of those harms, rendered the
warnings or instructions of the manufacturer inadequate and the manufacturer could
have provided the warnings or instructions which the claimant alleges would have
been adequate.
RCW 7. 72. 030( l)( b).
45052 -6 -II
Despite the use of the term " negligence" in the statute, a manufacturer' s failure to warn is
Macias Saberhagen Holdings, Inc., 175 Wash. 2d 402,
generally governed
by a strict liability test. v.
409- 10, 282 P.3d 1069 ( 2012); Ayers v. Johnson & Johnson Baby Products Co., 117 Wash. 2d 747,
762- 63, 818 P.2d 1337 ( 1991). This interpretation mirrors the rule of the RESTATEMENT ( SECOND)
OF TORTS § 402A ( 1965), which " embodies a doctrine of strict liability with respect to products
which are introduced into the stream of commerce." Terhune, 90 Wash. 2d at 12. The standard is
strict liability because " even where a product is faultlessly designed, it may be considered
unreasonably unsafe if it is placed in the hands of the ultimate consumer unaccompanied by
adequate of dangers necessarily involved in its use." Terhune, 90 Wash. 2d at 12.
warning
Importantly, the Restatement makes an exception to the strict liability rule for products that
are " incapable of being made safe for their intended and ordinary use" but nevertheless are " fully
justified, notwithstanding the unavoidable high degree of risk.
119
RESTATEMENT ( SECOND) § 402A
cmt. k. Prime examples of such products are " drugs, vaccines, and the like, many of which for
this very reason cannot legally be sold except to physicians, or under the prescription of a
physician." RESTATEMENT ( SECOND) § 402A curt. k ( emphasis added). Similarly, the exception
applies to
new or experimental drugs as to which, because of lack of time and opportunity for
sufficient medical experience, there can be no assurance of safety, or perhaps even
of purity of ingredients, but such experience as there is justifies the marketing and
use of the drug notwithstanding a medically recognizable risk.
RESTATEMENT ( SECOND) § 402A cmt. k.
9 ISI admits that the da Vinci System is an " unavoidably unsafe" product, as that term is used in
RESTATEMENT ( SECOND) § 402A cmt. k. CP at 110.
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Our Supreme Court adopted comment k in Terhune, 90 Wash. 2d at 14- 15, and has
consistently held that it applied in cases involving medical products available only through a
physician, including WPLA actions. 10 Ruiz -Guzman, 141 Wash. 2d at 506- 08 ( citing Young v. Key
Pharms., Inc., 130 Wash. 2d 160, 167- 68, 922 P.2d 59 ( 1996) ( plurality opinion); Rogers, 116 Wash. 2d
at 197, 202- 04).
B. Who the Manufacturer Must Warn
The WPLA does not expressly specify who must receive the manufacturer' s warnings. See
RCW 7. 72. 030 ( 1)( b), ( c) ( referring to warnings provided " with the product" and warnings issued
after a product was manufactured to " inform product users"). However, the learned intermediary
doctrine directs that for certain medical products that are unavoidably unsafe, the " manufacturer' s
duty to warn of dangers associated with its product runs only to the physician; it is the physician' s
McKee, 113 Wash. 2d at 709 ( emphasis added). The reason
duty to warn the ultimate consumer."
for this doctrine is that when a medical product is available only by prescription (as is the da Vinci
System), the physician acts as a gatekeeper who stands in the place of the manufacturer in relation
to the patient. That is, the physician acts as a "` learned intermediary"' who undertakes the duty to
inform himself of the qualities and characteristics of those products which he prescribes for or
administers to or uses on his patients, and to exercise an independent judgment, taking into account
his knowledge of the patient as well as the product." Terhune, 90 Wash. 2d at 14. The patient places
primary reliance" on the physician' s informed judgment, rather than whatever warnings the
Terhune, 90 Wash. 2d at 14. Therefore, the physician is in a
manufacturer
may have included.
to Taylor argues that the learned intermediary doctrine may excuse a manufacturer from the
common law duty to warn a purchaser, but not the statutory duty to warn under RCW
7. 72. 030( 1)( b). But the WPLA preempts all common law products liability causes of action.
Wash. Water Power Co., 112 Wash. 2d at 853, 856. This preemption means that there is only one
duty to warn in products liability law. We address that duty in the foregoing analysis.
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superior position to warn the patient and the courts should not interfere with the physician -patient
relationship.
Taylor argues that IS I' s duty to warn also runs to Harrison Medical Center as the purchaser
of the da Vinci System and that the learned intermediary doctrine is inapplicable here; i.e, the
doctrine has no bearing on whether ISI has a duty to warn Harrison Medical Center. We disagree.
The fact that Harrison Medical Center purchased the product rather than Taylor arguably
distinguishes our Supreme Court' s medical products cases, where the patient actually purchased
the product at issue. See, e. g., Terhune, 90 Wash. 2d at 10- 11 ( intrauterine contraceptive device);
McKee, 113 Wash. 2d at 703- 04 ( prescription drug); Rogers, 116 Wash. 2d at 198- 99 ( blood products
130 Wash. 2d 162- 63 ( prescription drug). However, this
administered intravenously); Young, at
distinction is immaterial because the da Vinci System was used on Taylor and he suffered the harm
caused by that surgery. The learned intermediary doctrine is not concerned with who pays for the
product or who retains possession of the product. Rather, its rationale is based on the physician' s
role as gatekeeper who stands in the place of the manufacturer in relation to the patient to provide
products accessible by prescription. Here, Dr. Bildsten
warnings about unavoidably unsafe only
acted as the gatekeeper; i. e. the learned intermediary similar to the doctors who acted as
gatekeepers in Terhune, McKee, Rogers, and Young.
The dissent would hold that the learned intermediary doctrine does not apply to ISI' s duty
to warn Harrison Medical Center. The dissent' s analysis is premised on the idea that ISI had a
duty to warn Harrison Medical Center about the da Vinci System because Harrison Medical Center
purchased the product. Dissent at 2 (" 1 would hold that the learned intermediary doctrine does not
remove a manufacturer' s duty to warn a hospital about medical equipment purchased by that
hospital."). We disagree with the dissent that the learned intermediary doctrine operates by
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removing a manufacturer' s duty to warn. Rather, we understand the doctrine as directing that
manufacturers of "unavoidably unsafe products" satisfy their duties under the WPLA by providing
warnings solely to learned intermediaries.
We now address Taylor' s instructional challenges.
C. Harrison Medical Center Is Not a Second Learned Intermediary
Taylor argues that the trial court erred by failing to instruct the jury that ISI had a duty to
warn Harrison Medical Center. ISI argues that the court correctly instructed the jury that ISI' s
duty to warn ran only to Dr. Bildsten. We agree with ISI and affirm the trial court.
No one disputes that as the prescribing physician, Dr. Bildsten is a learned intermediary.
Further, no one disputes that under the learned intermediary doctrine, ISI had a duty to provide
warnings to Dr. Bildsten. The issue Taylor raised is, if the learned intermediary doctrine applies,
whether the hospital acted as a second learned intermediary, meaning that ISI also had a duty to
provide warnings to Harrison Medical Center.
We review this question of first impression in Washington by reviewing the policies behind
the learned intermediary doctrine as noted above. Those policies convince us that the hospital
does not share in the physician' s role as a learned intermediary. The learned intermediary doctrine
singles out the physician " because it is he who finally controls the dispensing of the product."
Terhune, 90 Wash. 2d at 16. Here, Dr. Bildsten held final control over the use of the da Vinci System.
Dr. Bildsten examined Taylor, took his individualized circumstances into account, discussed
several potential courses of treatment with Taylor, warned him of the risks, and made the ultimate
decision to employ the da Vinci System.
Taylor argues that if Harrison Medical Center had not purchased the da Vinci System,
Taylor would not have received a da Vinci System surgery. But a third party that facilitates the
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distribution of a medical product, yet does not exercise its own individualized medical judgment,
is not a learned intermediary. In McKee, our Supreme Court considering a closely related issue
held that a pharmacist owed no duty to warn the patient -because
n] either manufacturer nor pharmacist has the medical education or knowledge of
the medical history of the patient which would justify a judicial imposition of a
duty to intrude into the patient
physician - relationship. In deciding whether to use
a prescription drug, the patient relies primarily on the expertise and judgment of the
physician.... Requiring the pharmacist to warn of potential risks associated with
a drug would interject the pharmacist into the physician -patient relationship and
interfere with ongoing treatment. We believe that duty, and any liability arising
therefrom, is best left with the physician.
113 Wash. 2d at 711- 712.
Like the pharmacist in McKee, Harrison Medical Center did not take Taylor' s
individualized circumstances or medical history into account. Nothing in the record indicates that
Harrison Medical Center played any role in deciding whether Taylor should receive a da Vinci
System surgery. Harrison Medical Center did not and could not exercise independent medical
judgment in Taylor' s specific case. It merely made the da Vinci System available for physicians,
like Dr. Bildsten, and credentialed them. But as McKee demonstrates, a party that simply enables
a medical product to get to a patient does not share the special type of relationship with the patient
as does the prescribing physician.
Our Supreme Court' s policy of deferring to the physician -patient relationship applies in
711- 12; Terhune, 90 Wash. 2d 14- 15. Dr.
g., McKee, 113 Wn.2d
at
full to this case. See, e. at
Bildsten, the prescribing physician, bore the ultimate decision- making responsibility, and under
the learned intermediary doctrine ISI fully complied with its duty to warn by warning Dr. Bildsten.
We reject Taylor' s invitation to extend the learned intermediary rule to a hospital that does not
exercise patient -specific medical judgment. The trial court did not err by instructing the jury that
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ISI' s duty to warn ran to Dr. Bildsten. And the trial court did not err by refusing to instruct the
jury that ISI' s duty to warn also ran to Harrison Medical Center.
D. Standard of Liability for Duty to, Warn
established who must receive warnings ( the physician), we now turn to what kind
Having
of warning must be given. Taylor argues that the trial court improperly applied a negligence
standard based on its erroneous application of comment k to the RESTATEMENT ( SECOND) § 402A.
Taylor argues that the proper standard for its failure -to -warn claim is strict liability. We disagree
and hold that a negligence standard governs the duty to warn a learned intermediary about a
medical product.
In Rogers, our Supreme Court held that comment k applies to blood and blood products,
and that a manufacturer of such products is " liable in negligence and not in strict liability" if it
fails to provide adequate warnings. 116 Wash. 2d at 207. This rule came about because a
manufacturer of an unavoidably unsafe product is liable for failure to warn only if it knew or should
have known of the defect. Rogers, 116 Wash. 2d at 207 ( citing Brown v. Superior Court, 44 Cal. 3d
1049, 1059, 751 P.2d 470, 245 Cal. Rptr. 412 ( 1988)). This knowledge requirement is " an idea
which ` rings of negligence."' Rogers, 116 Wash. 2d at 207 ( internal quotation marks omitted)
quoting Brown, 44 Cal. 3d at 1059).
Here, Taylor alleges that ISI failed to warn physicians of dangers that it knew or should
have known about based on both the medical literature and the studies that indicate the da Vinci
System has a high learning curve. Like the failure -to -warn issue in Rogers, this question " rings of
116 Wash. 2d at 207 ( internal quotation marks omitted) ( citation omitted). Therefore,
negligence."
whether ISI failed to warn physicians of known dangers raises an issue of negligence. Rogers, 116
Wash. 2d at 207.
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Taylor argues that Rogers is distinguishable and the da Vinci System is not entitled to the
blanket exemption from strict liability for medical products that the Court acknowledged in Ruiz -
Guzman, 141 Wash. 2d at 511. Rather, Taylor argues that the da Vinci System should be treated like
a pesticide, and the applicability of comment k should be conditioned on a factual analysis of
whether the product' s value to society exceeds the harm it causes. See Ruiz -Guzman, 141 Wash. 2d
at 511 ( rejecting a blanket application of comment k to pesticides and opting instead for a product -
by -product approach). Taylor' s argument is unsupported by any Washington authority.
The presence of the physician as learned intermediary places medical products in a class
of their own, and justifies the " blanket exemption" referenced in Ruiz -Guzman. 141 Wash. 2d at 511,
508- 09. Unlike the pesticide in Ruiz -Guzman, the da Vinci System is a prescription product with
This fact is relevant because in a strict liability case, " the
access strictly controlled by a physician.'
reason why the warning was not issued is irrelevant, and the manufacturer is liable even if it neither
the defect." Brown, 44 Cal. 3d 1059 n. 4. That is, ordinarily a
knew nor could have known of at
manufacturer' s failure to warn will never be reasonable, and thus strict liability is warranted. But
when the manufacturer is required to utilize a trained, credentialed physician to get the product to
the consumer, the reason why a manufacturer fails to give a warning becomes relevant.
With medical products, the risks depend as much on the patient' s individual circumstances,
as assessed by a qualified physician, as the qualities of the product itself. The manufacturer has
no way of knowing at the outset what an individual patient' s needs will be. A manufacturer may
reasonably choose to defer to the treating physician' s medical judgment rather than attempting to
individual Hence, the blanket
impose blanket warnings that may not apply in an patient' s case.
exemption for medical products discussed in Ruiz -Guzman makes sense. The trial court did not
err by instructing the jury on the negligence standard. .
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D. Conclusion
We hold that the court properly instructed the jury with the " duty -to -warn" and negligence
instructions under the learned intermediary doctrine, as articulated in controlling medical products .
cases. Accordingly, we affirm.
A majority of the panel has determined that the remainder of this opinion lacks precedential
value and will not be printed in the Washington Appellate Reports. The remainder of this opinion
will be filed for public record in accord with RCW 2. 06. 040, it is so ordered.
I. EVIDENCE OF OTHER INCIDENTS
Taylor argues that the trial court abused its discretion when it excluded Taylor' s rebuttal
of Harrison Medical Center' s robotics program. ISI
evidence concerning the overall success
that the court excluded this rebuttal evidence under ER 403. ISI further argues
argues properly
that the trial court' s curative instruction mitigated any prejudice to Taylor. We agree with ISI.
A. Additional Facts
Before trial on Taylor' s WPLA claim, Taylor moved to exclude evidence " related to the
absence of subsequent injuries, accidents, or bad outcomes at the hands of surgeons other than Dr.
Scott Bildsten at Harrison Medical Center using the da Vinci robot." CP at 2626. The trial court
reserved its ruling.
During Taylor' s recross -examination, he asked ISI representative Sean O' Connor whether
he had expressed doubts about the quality of the da Vinci System program at Harrison Medical
Center. O' Connor said that he had not. When Taylor asked why, O' Connor responded that:
outside of this incident we' re talking about, [ the da Vinci System has] been a very
successful program. The surgeons that were involved from the beginning are still
involved today. The hospital made the decision to buy [ ISI] technology this past
December. They' re currently talking to our clinical team to buy another one. These
are all the same doctors that were involved in 2008 minus Dr. Bildsten. So if they
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were concerned about the quality the technology was providing to the patient care,
they wouldn' t be reinvesting in the program.
RP ( Apr. 22, 2013) at 855.
Taylor requested a sidebar and argued that O' Connor' s testimony improperly implied that
Taylor' s surgery was " the only incident with the da Vinci" and, thus, opened the door to evidence
of other mishaps with the da Vinci System. RP ( Apr. 24, 2013) at 1229- 30. As such, Taylor
offered proposed exhibit 304, a record of the first 233 robotic procedures at Harrison Medical
Center.
The trial court refused to admit exhibit 304, ruling that it had " very little probative value"
because there was " no indication of who the surgeons were, their experience, patient outcomes,"
and " no comparison of complication rates with nonrobotic
surgeries." RP ( Apr. 29, 2013) at 1428.
But the court did read a curative instruction to the jury stating:
Each side has its own view as to whether there were other incidents at Harrison
Medical Center] after Mr. Taylor' s incident. I have ruled that neither side should
present that evidence, and accordingly, I am instructing you to disregard Mr.
O' Connor' s testimony regarding whether or not there were other incidents in the
Harrison [ Medical Center] da Vinci program.,
CP at 4693.
B. Trial Court' s Ruling
We review an evidentiary challenge for abuse of discretion. Kappelman, 167 Wash. 2d at 6.
Similarly, a trial court has considerable discretion regarding whether the door is opened to a line
of inquiry. Burchfiel v. Boeing Corp., 149 Wash. App. 468, 490, 205 P.3d 145 ( 2009).
Here, Taylor sought to introduce evidence concerning 233 other surgeries utilizing the da
Vinci System. The court disagreed, pointing out that:
Aside from the other issues of hearsay and the business records, we don' t
have the ability and I' m not going to open the case up to inquire of the other
surgeries, were the complications actual complications, were they really bad, some
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sound bad, or were they minor, were they typical things that occur during the course
of regular surgeries.
Each side indicates if we were to get involved in this, it would be necessary
to question the doctors who performed the surgeries listed in the complications
chart.
RP ( Apr. 29, 2013) at 1428- 29. For these reasons, the court ruled that " the admission of this
evidence would be confusing and prejudicial." RP ( Apr. 29, 2013) at 1429.
Here, the specific circumstances of Taylor' s da Vinci System surgery— including his
preexisting conditions, his suitability for a robotic prostatectomy, and the particular procedure Dr.
Bildsten used in conducting the surgery— were crucial to the case. In contrast, Taylor did not (and
could not reasonably) offer details regarding the 233 other surgeries. But without this context, the
jury could not reasonably compare Taylor' s outcome to the outcomes in other surgeries involving
the da Vinci System. If O' Connor' s testimony improperly invited the jury to consider the da Vinci
System outside the specific context of Taylor' s case, the proper remedy was not to exacerbate the
error by introducing more evidence of outside matters. Rather, the proper remedy was to admonish
to consider other incidents, as the trial court did. The trial court did not abuse its
the jury not
discretion, and we affirm.
kl
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Melnick, J.
I concur:
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Sutton, J.
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Worswick, P. J., ( dissenting in part) — I agree with the majority that the trial court
properly instructed the jury to apply a negligence standard to Fred E. Taylor' s inadequate
warning claims. In addition, I agree that the trial court did not abuse its discretion when it
excluded rebuttal evidence concerning the overall success of Harrison Medical Center' s robotics
11
program. But I disagree with the majority' s conclusion that the " learned intermediary"
doctrine applies to Intuitive Surgical Inc.' s ( ISI) duty to warn Harrison.
While it is true that the rationale behind the learned intermediary doctrine is that the
physician serves the role of a gatekeeper, I would hold that the physician serves this gatekeeper
role only where the physician stands between a manufacturer and the person who the
manufacturer failed to warn.
Because physicians are gatekeepers between manufacturers and unwarned patients, the
physician protects the unwarned patients. Thus, the learned intermediary doctrine serves to
remove a manufacturer' s duty to warn the patient. But because the physician does not stand
between manufacturers and unwarned hospitals, the physician does not protect the unwarned
hospital. Thus, the learned intermediary doctrine does not remove a manufacturer' s duty to warn
hospitals about medical equipment purchased by that hospital. Because sufficient evidence
supports Taylor' s theory that ISI' s negligent failure to warn Harrison caused Taylor' s harm, I
would hold that the trial court erred by failing to give an instruction on whether ISI negligently
failed to warn Harrison and thereby caused Taylor' s harm.
ii
Terhune v. A. H. Robins Co., 90 Wash. 2d 9, 14, 577 P.2d 975 ( 1978) ( internal quotation marks
omitted).
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I. LEARNED INTERMEDIARY DOCTRINE
I would hold that the learned intermediary doctrine does not remove a manufacturer' s
duty to warn a hospital about medical equipment purchased by that hospital. In Terhune v. A.H.
Robins Co., our Supreme Court held that under the learned intermediary doctrine, the
manufacturer has no duty to warn a physician' s patient because the physician stands as a
learned intermediary" between the manufacturer and the unwarned patient. 90 Wash. 2d 9, 14,
577 P.2d 975 ( 1978) ( internal quotation marks omitted). The court explained its reasoning for
applying the learned intermediary doctrine:
Where a product is available only on prescription or through the services of a
physician, the physician acts as a " learned intermediary" between' the manufacturer
or seller and the patient. It is his duty to inform himself of the qualities and
characteristics of those products which he prescribes for or administers to or uses
on his patients, and to exercise an independent judgment, taking into account his
knowledge of the patient as well as the product. The patient is expected to and, it
be does place reliance upon that judgment. The physician
can presumed, primary
decides what facts should be told to the patient. Thus, if the product is properly
labeled and carries the necessary instructions and warnings to fully apprise the
physician of the proper procedures for use and the dangers involved, the
manufacturer may reasonably assume that the physician will exercise the informed
judgment thereby gained in conjunction with his own independent learning, in the
best interest of the patient. It has also been suggested that the rule is made
necessary by the fact that it is ordinarily difficult for the manufacturer to
communicate directly with the consumer.
90 Wash. 2d at 14 ( emphasis added) ( footnote omitted). Thus, a properly warned physician is a
learned intermediary between the manufacturer and the unwarned patient because by using
independent judgment to determine which medical products a patient should receive and what
information a patient needs to know about those medical products, the physician serves as a
gatekeeper between the manufacturer and the unwarned patient.
In McKee v. American Home Products Corp., the court held that pharmacists have no
duty to warn patients because physicians, not pharmacists, serve as the gatekeepers between the
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manufacturer and the unwarned patient. 113 Wash. 2d 701, 711- 12, 782 P.2d 1045 ( 1989). This is
because it is physicians, not pharmacists, who exercise independent judgment to determine
which medical products a patient should receive and what information a patient needs to know
about those products. See 113 Wash. 2d at 711- 12.
While a physician is the gatekeeper between the manufacturer and the unwarned patient,
a physician is not a gatekeeper between the manufacturer and the unwarned hospital because the
physician does not use independent judgment to determine which medical products a hospital
should receive and what information a hospital needs to know about those products. Rather, the
hospital exercises independent judgment to determine which medical products it should purchase
and receives information about those products directly from the manufacturer. Furthermore, _
unlike in the situation of a patient, it is not difficult for the manufacturer to communicate directly
with the hospital.
This case illustrates why the learned intermediary doctrine should not apply to a
manufacturer' s failure to warn a hospital that has purchased a medical product. Here, Harrison
purchased the " da Vinci System" and was responsible for credentialing physicians to use it.
Clerk' s Papers at 344. This required exercising independent judgment to determine which
physicians had sufficient experience in laparoscopic surgery to use the da Vinci System, the
amount and nature of training required of these physicians, and the number of proctored da Vinci
System surgeries required of these physicians. ISI had influence over Harrison' s independent
determinations: three ISI employees sat on the steering committee that designed Harrison' s
credentialing requirements. These independent determinations by Harrison could affect the
quality of the physicians' use of the da Vinci System, which could affect the patients. Therefore,
ISI' s failure to warn Harrison could harm Harrison, the physicians, and the patients. I would
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hold that because the physician is not a learned intermediary between manufacturers and
hospitals, the learned intermediary doctrine does not apply to a manufacturer' s failure to warn a
hospital that purchased a medical product.
II. INSTRUCTION ON FAILURE TO WARN HARRISON
I would hold that the trial court erred by failing to give an instruction on whether ISI
negligently failed to warn Harrison and thereby caused Taylor' s harm. A trial court is obligated
to provide a jury instruction on any theory of the case that is supported by substantial evidence.
Kelsey v. Pollock, 59 Wash. 2d 796, 798, 370 P.2d 598 ( 1962); Estate ofDormaier v. Columbia
Basin Anesthesia, PLLC, 177 Wash. 828, 851, 313 P.3d 431 ( 2013). Substantial evidence is a
App.
sufficient quantum to persuade a fair-minded, rational person of the truth of a declared
premise."' 177 Wn. App. at 851 ( quoting Helman v. Sacred Heart Hosp., 62 Wash. 2d 136, 147,
381 P.2d 605 ( 1963)). This requires more than speculation and conjecture. 177 Wash. App. at
852. An instructional error is not harmless if it prevents a party from arguing his or her theory of
the case. Chunyk & Conley/Quad-C v. Bray, 156 Wash. App. 246, 255, 232 P.3d 564 ( 2010).
One of Taylor' s theories of the case was that ISI' s negligent failure to warn Harrison led
Harrison to allow Dr. Scott Bildsten to use the da Vinci System on Taylor unsupervised despite
Dr. Bildsten' s inexperience, thus causing harm to Taylor. This theory was supported by
testimony that ( 1) no physician at Harrison had any significant knowledge about the da Vinci
System; ( 2) the medical research supported that physicians needed up to 250 surgeries with the
da Vinci System to be comfortable with it; (3) after ISI gave Harrison information suggesting
that two proctored surgeries was sufficient, Harrison required physicians to perform only two
proctored surgeries; ( 4) Dr. Bildsten used the da Vinci System unsupervised on Taylor after only
two proctored surgeries; ( 5) Dr. Bildsten needed far more than two proctored surgeries before
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safely operating the da Vinci System unsupervised; and ( 6) use of the da Vinci System
contributed to Taylor' s harm. This is substantial evidence to support that ISI' s negligent failure
to warn Harrison led Harrison to allow Dr. Bildsten to use the. da Vinci System on Taylor
unsupervised despite Dr. Bildsten' s inexperience, thereby causing harm to Taylor.
Allowing the learned intermediary doctrine to shield manufacturers in this instance
creates an environment that encourages manufacturers to refrain from disclosing dangers or
defects to the actual purchaser of the medical equipment. This skews the doctrine' s purpose.
I would hold that the learned intermediary doctrine did not apply to eliminate ISI' s duty
to warn Harrison about the da Vinci System purchased by Harrison. Because sufficient evidence
supports Taylor' s theory that ISI' s negligent failure to warn Harrison caused Taylor' s harm, I
would hold that the trial court erred by failing to give an instruction on that theory. Therefore, I
respectfully dissent in part.
rswick, P. J.
23