Taylor v. Intuitive Surgical Inc.

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This, opinion was fi~ {or record
at a()() 01'1\ onlW ~ l 21Ji 7
c::ifvJ``
SUSAN L. ·cARLSON
SUPREME COURT CLERK
IN THE SUPREME COURT OF THE STATE OF WASHINGTON
JOSETTE TAYLOR, as Personal Represe- )
sentative of the Estate of FRED E. TAYLOR,) No. 92210-1
deceased; and on behalf of the Estate of )
FRED E. TAYLOR; and JOSETTE ) EnBanc
TAYLOR, individually, )
)
Petitioner, ) Filed FEB 0 9 2017
)
v. )
)
INTUITIVE SURGICAL, INC., a foreign )
corporation doing business in Washington, )
)
Respondent. )
_____________________________)
OWENS, J.- Manufacturers have a duty to provide warnings to
consumers about the risks of their products pursuant to the Washington product
liability act (WPLA), chapter 7.72 RCW. In this case, a manufacturer sold a
surgical device to a hospital, which credentialed some of its physicians to
perform surgery with the device. The manufacturer's warnings regarding that
device are at the heart of this case. We are asked to decide whether the
manufacturer owed a duty to warn the hospital that purchased the device. The
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Taylor v. Intuitive Surgical, Inc.
No. 92210-1
manufacturer argues that since it warned the physician who performed the
surgery, it had no duty to warn any other party. We disagree because the
doctor is often not the product purchaser. We find that the WPLA requires
manufacturers to warn purchasers about their dangerous medical devices.
Hospitals need these warnings to credential the operating physicians and to
provide optimal care for patients. In this case, the trial court did not instruct the
jury that the manufacturer had a duty to warn the hospital that purchased the
device. Consequently, we find that the trial court erred. We vacate the defense
verdict and remand for retrial.
FACTS
Intuitive Surgical Inc. (lSI) is the manufacturer of a robotic surgical
device called the "da Vinci System," which surgeons use to perform
laparoscopic surgeries. lSI manufactures and markets the da Vinci System
robotic device to medical centers, including Harrison Medical Center, which
purchased the device. The device is used for robotic laparoscopic surgeries,
which are minimally invasive because surgeons remotely operate on the person
by inserting the robotic instruments into the patient through small incisions.
Since laparoscopic procedures use small incisions through the skin, the
recovery times are much shorter and the surgeries result in fewer complications
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Taylor v. Intuitive Surgical, Inc.
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than alternative methods. Presently, the da Vinci System is used in about 84
percent of prostatectomies in the United States.
The da Vinci System was used for the first time in 1997. In 2000, the
United States Food and Drug Administration cleared the da Vinci System for
certain surgeries, and it was cleared for prostatectomies in 2001. The da Vinci
System is not used on a patient unless a physician allows for its use. An expert
urologist testified that surgeons must be credentialed in order to use the da
Vinci System because it is one of the "most complex medical devices"
surgeons use. 11 Verbatim Report of Proceedings (VRP) (May 1, 2013) at
1912. Even with expertise in open surgery, a skilled surgeon would still need
training and experience to operate the da Vinci System successfully. Experts
testified at trial that "confidence" with the device is not achieved until a
surgeon has completed 150 to 250 procedures. Id. at 1948.
As part of its training, lSI requires that surgeons perform two proctored
surgeries, but hospitals enforce their own requirements for credentialing
surgeons to use the da Vinci System. Harrison Medical Center provided
credentials after those two proctored procedures. Other hospitals in
Washington provided credentials after three or four proctored surgeries. See 6
VRP (Apr. 22, 2013) at 774-75 (Tacoma General Hospital requiring three); 14
VRP (May 7, 2013) at 2408 (Swedish Medical Center requiring four). lSI
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Taylor v. Intuitive Surgical, Inc.
No. 92210-1
recommends that surgeons choose "simple cases" for initial unproctored
procedures. Clerk's Papers (CP) at 6029. lSI provided a user's manual to
doctors, containing various warnings related to the device. Three warnings are
particularly relevant to this case. First, as part of its training, lSI advised
surgeons not to perform prostatectomies on obese persons. lSI provided body
mass index (BMI) guidelines stating patients should have a BMI of less than
30. Second, lSI advised not to perform prostate procedures on persons who
previously underwent lower abdominal surgeries. Third, lSI warned that it was
unsafe for the patient not to be in a steep Trendelenburg position (tilted with
head downward) during the procedure.
Dr. Scott Bildsten had 15 years of experience performing open
prostatectomies, having performed between 80 and 100 such procedures prior
to Fred Taylor's surgery. He was also experienced with hand-assisted
laparoscopic procedures, in which the surgeon operates with one hand outside
of the patient's body and the other hand assisting the instruments inside of the
body. Dr. Bildsten had performed two proctored prostatectomies before
performing his first unproctored procedure on Taylor.
After receiving informed consent, Dr. Bildsten performed a robotic
prostatectomy on Taylor to treat his prostate cancer using the da Vinci System
on September 9, 2008. At the time of surgery, Taylor weighed 280 pounds and
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Taylor v. Intuitive Surgical, Inc.
No. 92210-1
had a BMl of39 (contrary to lSI's advice to choose a patient with a BMl of
less than 30). Dr. Bildsten testified that he considered Taylor to be "severely
obese." 7 VRP (Apr. 23, 2013) at 1140. Furthermore, Taylor had three prior
lower abdominal surgeries (which went against lSI's advice to avoid patients
with prior lower abdominal surgeries). During the surgery, Dr. Bildsten did not
position Taylor in the steep Trendelenburg position due to his weight (in spite
of lSI's advice to conduct the procedure in that position). Although
Dr. Bildsten knew that Taylor "was not an optimal candidate," he performed
the prostatectomy as his first unproctored procedure using the robotic system.
ld. at 1063.
During the surgery, Taylor suffered complications. Dr. Bildsten became
aware that Taylor's rectal wall was lacerated. He converted the procedure to an
open surgery, and another surgeon came in to fix the rectal tear. Taylor's
quality of life was poor after the surgery. He suffered respiratory failure
requiring ventilation, renal failure (that ultimately resolved itself), and
infection. He was incontinent and had to wear a colostomy bag. He also
suffered neuromuscular damage and could no longer walk without assistance.
Roughly four years after the surgery, Taylor passed away. A doctor testified
that the prostatectomy's complications hastened his death.
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Taylor v. Intuitive Surgical, Inc.
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A year after the surgery, Taylor filed suit against Dr. Bildsten, his
partner (Dr. John Hedges), their medical practice, and Harrison Medical Center.
He later added lSI. After he died, his wife, Josette Taylor, proceeded with the
lawsuit as personal representative of his estate. Before trial, Taylor 1 settled
with Drs. Bildsten and Hedges, their private practice, and Harrison Medical
Center. lSI was the only remaining defendant. Taylor proceeded against lSI
for claims of product defect, breach of warranty, breach of contract, violation
of Washington's Consumer Protection Act (ch. 19.86 RCW), negligence, and
product liability under the WPLA. The trial court granted summary judgment
in favor of lSI on all claims, except for Taylor's failure to warn claim under the
WPLA.
At trial, lSI presented expert testimony that described the lSI training
process. Dr. Joel Lilly, a urologist with significant robotic surgical experience,
discussed the lSI training course. lSI trained surgeons on "how to select your
best candidates for starting your experience," such as choosing "thin patients"
and those with no prior abdominal surgery. 14 VRP (May 7, 2013) at 2405.
Dr. Lilly told the jury that in his opinion, Dr. Bildsten was negligent in
performing Taylor's surgery.
1
We refer to both plaintiffs, Fred and Josette Taylor, as "Taylor" for convenience.
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Taylor v. Intuitive Surgical, Inc.
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The jury returned a verdict in favor of lSI. It found specifically that lSI
was not negligent in providing warnings or instruction to Dr. Bildsten. Taylor
appealed, raising several assignments of error. First, Taylor claimed that the
trial court erred by declining to instruct the jury that lSI had a duty to warn
Harrison Medical Center. The Court of Appeals found by a 2-1 decision that
the trial court did not err because lSI fulfilled its duty to warn by warning
Dr. Bildsten. Taylor v. Intuitive Surgical, Inc., 188 Wn. App. 776, 792,797-98,
355 P.3d 309 (2015) (published in part). Second, Taylor claimed that the trial
court erred by applying a negligence st.andard instead of a strict liability
standard. The Court of Appeals unanimously found that the trial court properly
applied a negligence standard to the inadequate warning claim. Id. at 794.
Third, Taylor claimed that the trial court erred by excluding Taylor's evidence
to rebut lSI's testimony that Harrison Medical Center's robotic surgery
program was successful overall. In the unpublished portion of its opinion, the
Court of Appeals unanimously agreed that the trial court did not abuse its
discretion by excluding this evidence as confusing and prejudicial. Taylor, slip
op. (unpublished portion) at 16-18, http://www.courts.wa.gov/Opinions.
Finally, Taylor challenged jury instructions on superseding cause and failure to
mitigate. Since the jury did not reach these issues and the Court of Appeals
affirmed the trial court, it did not reach these additional assignments of error.
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Taylor, 188 Wn. App. at 780 n.4. Here, Taylor seeks review ofthese
assignments of error. We granted review. Taylor v. Intuitive Surgical, Inc.,
184 Wn.2d 1033, 379 P.3d 957 (2016).
Four amici have filed briefs in this case. The Washington State
Association for Justice Foundation filed a brief in support of Taylor. The
Medical Device Manufacturers Association and National Association of
Manufacturers, the Washington State Hospital Association, and Product
Liability Advisory Council Inc. filed briefs in support of IS I.
ISSUES
1. Did lSI have a duty to warn Harrison Medical Center as the purchasing
hospital of the da Vinci System?
2. Did the trial court properly apply a negligence standard, as opposed to
strict liability, to Taylor's inadequate warnings claim?
3. Did the trial court err when it excluded Taylor's proposed rebuttal
evidence to testimony that Harrison Medical Center's robotics program was
successful overall?
4. Did the trial court err by instructing the jury on superseding cause or
failure to mitigate?
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Taylor v. Intuitive Surgical, Inc.
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ANALYSIS
Taylor claims the trial court erred in four ways. First, Taylor claims the
trial court erred by not instructing the jury on lSI's duty to warn Harrison·
Medical Center as the purchasing hospital. Second, Taylor claims the trial
court erred in its application of the negligence standard rather than strict
liability. Third, Taylor claims the trial court erred by excluding Taylor's
rebuttal evidence to lSI's testimony that Harrison Medical Center's robotics
surgery program was successful overall. Fourth, Taylor claims the trial court
erred by instructing the jury on superseding cause and failure to mitigate. As
explained below, we find that the trial court erred by not instructing the jury on
lSI's duty to warn the purchasing hospital. Accordingly, we vacate the defense
verdict and remand for retrial. Although we need not reach Taylor's additional
claims, we reach them to provide guidance for the trial court should these
issues arise on retrial.
1. Manufacturers Have a Duty To Warn Hospitals That Purchase
Medical Products
We find that the WPLA imposes a duty on manufacturers of medical
products to warn hospitals of the products' dangers when they purchase them.
The manufacturer's duty to warn purchasing hospitals is not excused when a
manufacturer warns doctors who use the devices because hospitals need to
know the dangers of their own products, which cannot be accomplished simply
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Taylor v. Intuitive Surgical, Inc.
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by the manufacturer's warnings to the doctor who uses the product. Thus, we
conclude that the trial court erred by failing to instruct the jury there was a duty
to warn Harrison Medical Center of the da Vinci System's risks.
A. Manufacturers Have a Duty under the WPLA To Warn
Purchasing Hospitals ofProduct Dangers with the Product
For the reasons explained below, we find that the WPLA provides a
statutory duty that manufacturers must warn purchasers of its dangerous
products. 2 Although the duty is not explicitly stated in the text of the statute,
the WPLA requires that warnings be provided with products. Since warnings
must be provided "with" products, manufacturers like lSI have a duty to
provide warnings to the purchaser of the product-in this case, Harrison
Medical Center.
The WPLA governs product-related harm claims based on a
manufacturer's failure to warn. Macias v. Saberhagen Holdings, Inc., 175
Wn.2d 402, 409, 282 P.3d 1069 (2012); RCW 7.72.010(4), .030. We have held
that the "WPLA is the exclusive remedy for product liability claims," including
claims for inadequate warnings. Macias, 175 Wn.2d at 409.
The WPLA was enacted in 1981 and closely mirrors the Restatement
(Second) of Torts§ 402A (Am. Law. Inst. 1965), which we adopted in a series
2
lSI dedicated several pages of its briefing to defend against a "duty to train" standard.
While Taylor argued that lSI had a duty to train to the trial court, Taylor does not raise
that claim to this court.
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Taylor v. Intuitive Surgical, Inc.
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of cases prior to the enactment of the WPLA. See LAws OF 1981, ch. 27;
Terhune v. A.H Robins Co., 90 Wn.2d 9, 12, 577 P.2d 975 (1978); see also
Ulmer v. Ford Motor Co., 75 Wn.2d 522, 531-32, 452 P.2d 729 (1969)
(adopting the Restatement's liability standard for a manufacturer case). Thus,
although the WPLA governs product harm claims, some case law regarding
product harm cases comes from Restatement principles.
Here, Taylor argues that the manufacturer's duty to warn exists in the
plain text of the WPLA. Taylor is correct. The WPLA provides standards for
product manufacturers and the basis for claims where "the claimant's harm was
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). A product is
not reasonably safe due to inadequate warnings where the likelihood and
seriousness of the harms the product could cause "rendered the warnings or
instructions of the manufacturer inadequate" and could have been provided. Id.at (1 )(b).
The WPLA does not specify who should receive these warnings.
However, it states that "[a] product is not reasonably safe because adequate
warnings or instructions were not provided with the product . ... " !d.
(emphasis added). On one hand, the statute discusses inadequate warnings
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Taylor v. Intuitive Surgical, Inc.
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owed "with the product" for products where at the time of manufacture, there
was a likelihood the product would cause the plaintiffs harm. !d. On the other
hand, it discusses that warnings provided after the product was manufactured
be given to "product users." Id. at (l)(c). Since the product is owned and
maintained by the purchasing hospital, it follows from the text of the statute
that the purchaser is owed product warnings with the product it purchases.
Especially here, where the product is an extremely complex and
inherently dangerous medical device, it is logical that hospitals would need
warnings. We have held that hospitals have an independent duty of care to
their patients. Pedroza v. Bryant, 101 Wn.2d 226, 232-33, 677 P.2d 166(1984). Both parties recognize this. During summary judgment argument,
lSI's counsel acknowledged that "Harrison Medical Center had an independent,
nondelegable duty to credential and to perform a due-diligence evaluation to
determine whether Dr. Bildsten was competent to perform surgery with the
da Vinci [System] without supervision." VRP (Feb. 26, 2013) at 37. Although
we have recognized that hospitals do not have a duty to intervene in the doctor-
patient relationship, Howell v. Spokane & Inland Empire Blood Bank, 114
Wn.2d 42, 55, 785 P.2d 815 (1990), hospitals are required by law to adopt
credentialing requirements regarding staffing. See RCW 70.41.230; WAC 246-
320-161; 42 C.F.R. § 422.204. Harrison Medical Center has a credentialing
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Taylor v. Intuitive Surgical, Inc.
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process and it cleared Dr. Bildsten to use the da Vinci System for the
prostatectomy here. Thus, it follows that hospitals need product warnings to
design a credentialing process that will keep patients as safe as possible.
The Washington State Hospital Association argues in its amicus brief in
support of lSI that the hospital is not in the best position to determine what
procedure should be performed. Br. of Amicus Curiae Wash. State Hosp.
Ass'n at 13. However, just because the physician is in the best position to
make a decision regarding a patient's treatment, the hospital is not completely
absent from the process. In Pedroza, we adopted the doctrine of corporate
negligence to address negligence beyond that of the physician, to recognize the
onus on the hospital itself for the competency of the hospital's medical staff.
101 Wn.2d at 231-33. There, we observed that in addition to the physicians
themselves, "[h]ospitals are also in a superior position to monitor and control
physician performance." Id. at 231. In adopting that doctrine, we recognized
the "public's perception of the modern hospital as a multifaceted health care
facility responsible for the quality of medical care and treatment rendered." !d.
We reasoned that imposing the doctrine of corporate negligence on hospitals
and requiring them to assume responsibility would provide "hospitals a
financial incentive to insure the competency of their medical staffs." Id. at 232.
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It is true that the hospital, as an entity, did not have a one-on-one
relationship with Taylor-Dr. Bildsten did. However, as we have appreciated,
hospitals must maintain a high standard of care for the benefit of their patients.
As it pertains to the da Vinci System, hospital personnel are actively involved
in credentialing doctors to use the device. The hospital simply cannot maintain
the high standard that the law requires by excusing manufacturers from the duty
to provide them information about devices that they own. Knowing the risks of
the da Vinci System is necessary in order to allow hospitals to impose stricter
credentialing processes as needed. Certainly an airplane manufacturer does not
only supply a user's manual to the pilots-the airline owner needs a copy as
well. It is in the best interest of all parties for warnings to be provided, but
particularly for patients, who trust that their safety is a priority. The WPLA is
concerned with the safety of product users, which is why it explains what
makes a product unsafe. It requires warnings for these dangerous products in
order to make them safe. Thus, the manufacturer's duty to warn hospitals is
embedded in the text of the WPLA itself.
Prior to the adoption of the WPLA, we adopted the learned intermediary
doctrine, which flowed from a comment to the Restatement that discussed the
interpretation of products liability principles to dangerous medical products.
The applicability of that doctrine is discussed in the next section.
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B. The Learned Intermediary Doctrine Does Not Apply to This Case
Under the learned intermediary doctrine, manufacturers of medical
products can satisfy their duty to warn patients of the risks of their products by
providing those warnings to the doctors prescribing the products. The
manufacturer's duty to provide warnings to patients transfers to the doctor, who
is in a better position to communicate them to the patient. In this case, lSI
contends that the manufacturer's duty to warn the hospital, which buys the
product, is similarly met by providing those warnings to the doctor using the
product. We reject this reasoning because the WPLA imposes a separate and
distinct duty for the manufacturer to provide warnings to the purchaser of the
product. Hospitals cannot meet their own duty to patients without knowing the
risks of the dangerous medical products they own.
i. Background on the Learned Intermediary Doctrine
We have found that under the learned intermediary doctrine, the
manufacturer satisfies its duty to warn the patient of the risks of its product
where it properly warns the prescribing physician. Terhune, 90 Wn.2d at 14.
We have explained the policy behind the doctrine as follows:
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.
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The patient is expected to and, it can be presumed, does place
primary reliance upon that judgment. The physician 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.
!d. (footnote omitted). Thus, although the manufacturer has a duty to warn
patients of product risks, it can satisfy this duty by warning the doctor (the
learned intermediary), who then takes on the responsibility of communicating
those warnings to the patient. !d. at 17.
Here, we are asked the novel question of whether the manufacturer's
duty to warn the hospital also can be satisfied by warning the doctor. However,
as explained below, the doctor is not a learned intermediary between the
manufacturer and the hospital, and thus the doctrine does not apply here.
ii. The Learned Intermediary Doctrine Does Not Apply To
Excuse the Mamifacturer's Duty To Warn the Purchasing
Hospital
As stated above, the learned intermediary doctrine's focus is on the
warnings to the patient and the doctrine releases the manufacturer's duty to
warn the patient where it provides warnings to the learned intermediary
physician. Here, lSI argues that a manufacturer need not warn any other party
where it has warned the prescribing physician. As explained below, this
argument fails because the manufacturer has an independent duty to warn the
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purchaser of the product and because physicians do not function in the same
intermediary capacity between the manufacturer and purchaser.
The dissenting judge for the Court of Appeals explained why the learned
intermediary doctrine does not apply in this case: the "doctrine does not remove
a manufacturer's duty to warn hospitals about medical equipment purchased by
that hospital." Taylor, 188 Wn. App. at 795 (Worswick, J., dissenting in part).
That duty to warn the purchaser is independent of the duty to warn the patient.
The judge explained, "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 . ... " Id. at 796 (Worswick, J.,
dissenting in part). Hospitals have an independent duty to ensure a device is
used safely. They can meet that duty only if they are informed of the risks of
using a device. Physicians do not function as an intermediary with a duty to
warn the hospital of the risks of a device, so nothing about the learned
intermediary doctrine applies here.
Both parties point to one case for support, in which we relied on the
learned intermediary doctrine to hold that pharmacists do not have a duty to
warn patients about prescription drugs they provide patients. McKee v. Am.
Home Prods. Corp., 113 Wn.2d 701, 720, 782 P.2d 1045 (1989). However,
McKee is not helpful to this case. McKee presented the question of whether the
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pharmacist had a duty to warn the patient about a medication in addition to the
physician who prescribed the medication. Id. at 707. In that case, we
compared the pharmacist to the manufacturer and found that the pharmacist did
not have to separately warn the patient because the doctor, as learned
intermediary, had already done so. Id. at 711. That analysis has no bearing
here because this case involves a separate duty that flows from the
manufacturer to the purchaser and is not about whether a learned intermediary
cuts off the duty to warn patients.
This doctrine should not serve to excuse the manufacturer's duties to
warn other entities to ensure the safety of persons its product will be used on.
Since the learned intermediary doctrine underscores the importance of patient
safety, it would be illogical if the doctrine was used to excuse another avenue
to achieve that goal. If patient safety is the goal, then it requires all hands on
deck. While doctors are recognized as the gatekeepers between the
manufacturer and the patient, the hospital is the gatekeeper between the
physician and the use of the da Vinci System since the hospital clears surgeons
to use it. Thus, the hospital must have warnings about its risks and no tort
doctrine should excuse the manufacturer from providing them.
Thus, the learned intermediary doctrine does not excuse the
manufacturer's WPLA duty to warn the hospital because it pertains to the
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Taylor v. Intuitive Surgical, Inc.
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manufacturer's duty to warn only the patient, not the product purchaser.
Consequently, we find that the trial court erred by declining to give the jury an
instruction on lSI's duty to warn Harrison Medical Center. Based on that error,
we vacate the defense verdict and remand for retrial. To provide guidance to
the parties on retrial, we address Taylor's other arguments below.
2. The Strict Liability Standard Governs Inadequate Warning Claims on
Dangerous Medical Products Like the da Vinci System
Taylor argues that the trial court erred by applying a negligence standard
to her WPLA failure to warn claim because strict liability governs such claims.
In this instance, we agree. Our case law on this issue is unsettled, and there is
no binding precedent that requires adoption of a negligence standard when
inadequate warnings are given. We instead follow the plain language of
Restatement § 402A and hold that the usual strict liability standard applies to
failure to warn claims.
Under the WPLA, a manufacturer is liable where the plaintiff's harm
was "proximately caused by the negligence of the manufacturer" as to design or
inadequate warning. RCW 7. 72.03 0( 1). However, strict liability generally
governs product liability claims because of the common law foundation of the
WPLA. Mqcias, 175 Wn.2d at 409-10. A strict liability standard is also used
in Restatement § 402A, which this state adopted. One comment to § 402A,
which we have likewise adopted, provides an exception to the application of
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strict liability for "unavoidably unsafe products." RESTATEMENT (SECOND) OF
TORTS: SPECIAL LIABILITY OF SELLER OF PRODUCT FOR PHYSICAL HARM TO
USER OR CONSUMER § 402A cmt. k. (AM. LAW lNST. 1965). Comment k
states:
Unavoidably unsafe products. There are some products which, in
the present state of human knowledge, are quite incapable of being
made safe for their intended and ordinary use. These are especially
common in the field of drugs. An outstanding example is the
vaccine for the Pasteur treatment of rabies, which not uncommonly
leads to very serious and damaging consequences when it is
injected. Since the disease itself invariably leads to a dreadful death,
both the marketing and the use of the vaccine are fully justified,
notwithstanding the unavoidable high degree of risk which they
involve. Such a product, properly prepared, and accompanied by
proper directions and warning, is not defective, nor is it
unreasonably dangerous. The same is true of many other 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. It is also true in particular of many 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. The seller of such products, again
with the qualif1cation that they are properly prepared and marketed,
and proper warning is given, where the situation calls for it, is not
to be held to strict liability for unfortunate consequences attending
their use, merely because he has undertaken to supply the public
with an apparently useful and desirable product, attended with a
known but apparently reasonable risk.
Thus, where a product is inherently dangerous by nature but is still desirable
because of its public benefit, it is an "unavoidably unsafe product" under
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Taylor v. Intuitive Surgical, Inc.
No. 92210-1
comment k. Comment k exempts such products from strict liability under
§ 402A.
But comment k specifies that the exception is not available to a
manufacturer who fails to adequately warn. Comment k states that "[t]he seller
of such products, again with the qualification that they are properly prepared
and marketed, and proper warning is given, where the situation calls for it, is
not to be held to strict liability." !d. (emphasis added). Thus, by its express
terms, proper preparation, marketing, and warnings are prerequisites to a
manufacturer being able to qualify for this exception to strict liability.
It should be noted that although proper warnings are a prerequisite to
application of the exception, comment k does not govern the adequacy of those
warnings. However, one thing is clear: comment k is an exception to§ 402A
strict liability. It thus applies only after the trier of fact determines the
prerequisites have been met. Comment k exempts a manufacturer from
§ 402A' s strict liability standard only if proper warnings accompanied the
product, and we must measure the adequacy of those warnings under § 402A
before applying the exception. To apply the standard of the exception before
its prerequisites have been met would allow the exception to swallow the rule.
Intuitive asserts that negligence, not strict liability, governs duty to warn
claims, arguing that "Washington and federal courts have had little difficulty in
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Taylor v. Intuitive Surgical, Inc.
No. 92210-1
holding a negligence standard applies to comment k cases." Revised Suppl. Br.
ofResp't at 16. However, this is not the case in Washington when a
manufacturer fails to provide adequate warnings. While this court has been
divided on this issue, there is no binding precedent that requires us to hold that
a negligence standard applies when determining whether comment k applies to
failure to warn claims. We instead follow the language of the comment itself
and hold that the usual strict liability standard applies here.
In Terhune, 90 Wn.2d at 12-13, we applied the comment k exception to
an intrauterine contraceptive device. However, in that case the evidence was
undisputed that the defendant warned the plaintiffs physician of the danger of
perforation of the uterus upon insertion of the device. The court rejected an
argument that the defendant owed a duty to warn the plaintiff patient directly.
While the court acknowledged that comment k "does not purport to state what
is 'proper warning' where [an unavoidably unsafe] product is involved," id. at
13, the court clarified that the warning was proper in that case, stating that a
manufacturer "fulfills its duty if it warns the physician of the dangers attendant
upon its use, and need not warn the patient as well." !d. at 17.
Following Terhune, we answered a certified question asking whether
comment k applied to blood products. Rogers v. Miles Labs., Inc., 116 Wn.2d
195, 802 P.2d 1346 (1991). The court in Rogers held that the comment k
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Taylor v. Intuitive Surgical, Inc.
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exception did apply. However, even though Rogers did not involve an
inadequate warning claim, in dicta the court posed a hypothetical, stating,
It might be argued that, in order fully to resolve the question
whether strict liability applies, we must also resolve whether
defendants met their duty to warn under comment k. The argument
would be that if defendants did not qualify for the comment k
exception, then the overall rule-strict liability-would apply.
I d. at 207. The court then expressed agreement with the reasoning of a
California case applying a negligence standard. I d. (citing Brown v. Superior
Court, 44 Cal.3d 1049, 1059, 751 P.2d 470 (1988)).
This passage was unnecessary to resolve the certified question at issue,
and has never been applied by a majority of this court. In Young v. Key
Pharm., Inc., 130 Wn.2d 160, 167-69, 922 P.2d 59 (1996), a four-justice lead
opinion relied on Rogers, requiring a negligence standard for failure to warn
claims with respect to unavoidably unsafe products. However, the four-justice
"dissent" concluded that Rogers was not binding authority on the standard for
failure to warn claims, explaining, "Rogers wrongly applied comment k and
Washington law. Exemption from strict liability under comment k is expressly
limited to products accompanied by adequate warnings. Stated another way-
adequate warnings are a predicate to application of comment k by the express
terms of the comment." Id. at 184 (Madsen, J., dissenting).
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Taylor v. Intuitive Surgical, Inc.
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Since Young, this court addressed comment k another time, but again not
in the context of an inadequate warnings claim. In Ruiz-Guzman v. Amvac
Chern. Corp., 141 Wn.2d 493, 496, 7 P.3d 795 (2000), the sole question
pertaining to comment k was whether a pesticide could qualify as an
"unavoidably unsafe product" under Restatement § 402A. A failure to warn
claim was not raised. The court noted, however, that "[b]ecause comment k
was not expressly provided for in the WPLA, we must be sparing in its
application lest we defeat the letter or policy of the WPLA." Id. at 506. Thus,
the issue remains unresolved.
Because no binding precedent in Washington requires adoption of a
negligence standard here, we follow the language of the Restatement itself and
hold that the comment k exception is not available to a manufacturer who fails
to adequately warn. Comment k provides that a product is "unavoidably
unsafe" only when it is otherwise properly prepared and accompanied by
adequate warnings; thus, the exception applies only after the trier of fact
determines that the prerequisites have been met. The adequacy of a
manufacturer's warnings are to be measured under Washington's strict liability
test. Maintaining strict liability for these claims is essential to the purpose of
comment, which is to safeguard the public to the greatest extent possible
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Taylor v. Intuitive Surgical, Inc.
No. 92210-1
without discouraging the development and marketing of unavoidably unsafe
products. We reverse the trial court's application of negligence in this case.
3. The Trial Court Did Not Err in Prohibiting Taylor's Rebuttal
Evidence
Taylor also argues that the trial court erred by excluding one exhibit that
Taylor proposed to rebut one witness' testimony. We find that the trial court
was within its discretion to exclude Taylor's proposed rebuttal evidence in
response to an lSI witness' assertion that the robotics program at Harrison
Medical Center was successful overall. The trial judge correctly recognized
that the proffered evidence was complicated and might have confused the jury.
More importantly, the trial court gave a curative instruction to limit any
prejudice from the lSI witness' assertion.
First, some additional facts are necessary to evaluate this issue. Before
trial, Taylor filed a motion in limine to exclude evidence of the absence of
subsequent accidents using the da Vinci System at Harrison Medical Center.
At trial, lSI put forth testimony from Sean O'Connor, the lSI representative
who worked with Harrison Medical Center, who testified about Harrison's
robotics program. When Taylor cross-examined O'Connor, Taylor asked
O'Connor whether he had doubts about the success of the robotics program.
When O'Connor said no, Taylor asked why. O'Connor responded that "outside
of this incident we're talking about, it[']s been a very successful program."
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6 VRP (Apr. 22, 2013) at 855. A few days later, Taylor offered exhibit 304, a
record of 233 surgeries at Harrison Medical Center, to rebut the overall success
of the program. The document listed all robotic procedures and notations about
complications. Taylor argued that O'Connor's testimony opened the door to
that list. The trial court excluded the evidence as confusing and prejudicial, but
gave the following curative instruction:
Each side has its own view as to whether there were other
incidents at Harrison 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 da Vinci
program.
CP at 4693. The Court of Appeals affirmed. Taylor, slip op. (unpublished
portion) at 16-18.
In general, when one party opens the door to a topic, the other party may
also introduce evidence in order to establish the truth for the jury. State v.
Gefeller, 76 Wn.2d 449, 455, 458 P.2d 17 (1969). However, all evidence must
be relevant. ER 402. Even relevant evidence is limited where its probative
value is substantially outweighed by the danger of unfair prejudice, confusion
of the issues, or misleading the jury. ER 403. We review evidentiary
challenges for an abuse of discretion. Kappelman v. Lutz, 167 Wn.2d 1, 6, 217
P.3d 286 (2009). A trial court's decision on excluding evidence will be
reversed only where it was based on untenable grounds or reasons. !d.
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Here, excluding exhibit 304 was not an abuse of discretion because in
the trial court's assessment, the exhibit was confusing and prejudicial. First,
lSI did not open the door to this evidence since Taylor was questioning
O'Connor-not lSI. Second, exhibit 304likely would have confused the jury
because it was not offered contemporaneously with O'Connor's testimony or
with an expert who could explain the significance of the notations regarding the
complications. The jury would not know whether the complications were
minor or serious, or whether the various procedures were comparable to
prostatectomies. Third, the judge issued a limiting instruction. As the Court of
Appeals observed, if admitting O'Connor's testimony was problematic in the
first instance, the proper remedy would not be to pile on confusing evidence.
The proper remedy was to provide a limiting instruction, which the trial court
did. Consequently, we find that the trial court did not abuse its discretion in
excluding exhibit 304.
4. The Trial Court Did Not Err by Giving Jury Instructions on
Superseding Cause or Failure To Mitigate
Taylor raises two additional alleged instructional errors. Taylor claims
that the trial court erred by instructing the jury on Dr. Bildsten's negligence as
a superseding cause and Taylor's own failure to mitigate. Since the jury did
not reach these issues because it found in favor of the defendant and the Court
of Appeals affirmed, the Court of Appeals declined to reach these issues.
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Taylor v. Intuitive Surgical, Inc.
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However, we reach these issues to provide guidance to the parties should the
issues come up again on remand. As explained below, since evidence
supported the defendant's theories on these issues, the trial court acted within
its discretion by providing these instructions.
In general, whether to give a particular instruction is within the trial
court's discretion. Stiley v. Block, 130 Wn.2d 486, 498, 925 P.2d 194 (1996).
Where substantial evidence supports a party's theory of the case, trial courts are
required to instruct the jury on the theory. Id. We review a trial court's
decision to give a jury instruction "de novo if based upon a matter of law, or for
abuse of discretion if based upon a matter of fact." Kappelman, 167 Wn.2d at
6. That means that where the parties' disagreement about an instruction is
based on a factual dispute, it is reviewed for an abuse of discretion. State v.
Walker, 136 Wn.2d 767, 771-72, 966 P.2d 883 (1998). To determine whether
to give an instruction, the trial judge "must merely decide whether the record
contains the kind of facts to which the doctrine applies." Kappelman, 167
Wn.2d at 6.
a. Superseding Cause
The trial court instructed the jury on Dr. Bildsten's negligence as a
superseding cause that cut offiSI's liability. Taylor objected to the instruction,
arguing Dr. Bildsten's actions were not independent ofiSI's duty to warn. In
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Taylor v. Intuitive Surgical, Inc.
No. 92210-1
general, we have agreed that the superseding cause theory applies to product
liability actions. Campbell v. ITE Imperial Corp., 107 Wn.2d 807, 814, 733
P.2d 969 (1987). Washington courts have found that superseding cause
instructions are properly given in a failure to warn case where the manufacturer
provided warnings, but the manufacturer did not foresee that the consumer
would fail to heed that warning. See, e.g., Minert v. Harsco Corp., 26 Wn.
App. 867, 874-75, 614 P .2d 686 (1980). Here, the facts adduced at trial show
that Dr. Bildsten was negligent despite being given very specific warnings. He
failed to heed warnings about not choosing patients with a BMI of over 30
and/or prior lower abdominal surgeries. Thus, the facts in the record indicate
that his negligence may have been a superseding cause. The trial court was
within its discretion to instruct the jury on superseding cause.
b. Failure To Mitigate
The trial court instructed the jury that it could consider Taylor's own
alleged failure to mitigate. Taylor objected to the instruction, arguing that
giving the instruction was inappropriate because the verdict form allowed the
jury to deduct damages twice. Washington law states that the plaintiff's failure
to mitigate can be considered under the comparative fault statute. RCW
4.22.005. The statute states that the conduct of both parties is considered when
determining damages. RCW 4.22.015. We have held that a "plaintiff's
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Taylor v. Intuitive Surgical, Inc.
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negligence directly reduces plaintiffs recovery by the percentage of negligence
involved." ESCA Corp. v. KPMG Peat Marwick, 135 Wn.2d 820, 830, 959
P.2d 651 (1998). Here, it was appropriate for the trial court to include the
instruction to consider any potential mitigation of other parties, as facts were
adduced at trial about the fault of Dr. Bildsten and Taylor. The verdict form
allowed a place for the jury to fill in percentages of fault and does not indicate
double deduction, as Taylor contends. Thus, the trial court was within its
discretion to provide the failure to mitigate instruction.
CONCLUSION
We find that pursuant to the WPLA, manufacturers have a duty to warn
hospitals about the dangers of their products. The manufacturer's warnings to
Dr. Bildsten did not excuse its duty to warn Harrison Medical Center. As such,
we find that the trial court erred in failing to instruct the jury on this duty. We
vacate the jury's defense verdict and remand for a new trial. Further, we hold
that the comment k exception in Restatement § 402A is not available to a
manufacturer who fails to adequately warn and reverse the trial court's
application of negligence in this case.
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Taylor v. Intuitive Surgical, Inc.
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WE CONCUR:
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Taylor, Pers. Rep. of Estate of Taylor v. Intuitive Surgical, Inc.
No. 92210-1
MADSEN, J. (dissenting)-! agree with the majority that strict liability governs
inadequate warning claims on dangerous medical products because the exception found
in comment k to section 402A of the Restatement (Second) of Torts (Am. Law. Inst.
1965) is predicated on adequate warnings being given. And I agree that Intuitive
Surgical Inc. (lSI) had a duty to warn Harrison Medical Center of the dangers of the "da
Vinci System" surgical device when Harrison purchased that product. I write separately,
however, because even though this duty exists, it is not a duty that was owed to the
petitioner in this case. Therefore, the trial court did not err by not instructing the jury on
lSI's duty to warn Harrison.
Discussion
The majority holds that the Washington product liability act (WPLA), chapter 7.72
RCW, requires manufacturers to warn purchasers of the dangers of their products because
the WPLA states that a product is not reasonably safe if adequate warnings are not
provided with the product. See majority at 11 (citing RCW 7.72.030(1)(b)). Thus,
because Harrison was the purchaser of the da Vinci System, lSI had a duty to provide
warnings to Harrison. Although I concur with the majority's conclusion based on the text
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No. 92210-1
Madsen, J., dissenting
of the WPLA that lSI owed a duty to Harrison, I cannot agree that Josette Taylor
somehow has the ability to invoke this duty that was owed to Harrison.
Under the WPLA, a manufacturer must provide adequate warnings with its
product. RCW 7.72.030(1)(b); see majority at 10-11. This duty, however, is one that the
manufacturer owes the purchaser. The manufacturer must provide product warnings with
the product that the purchaser purchases. See majority at 11. Here, lSI would owe this
duty to Harrison. So if lSI breached this duty, Harrison would presumably have a claim
against lSI. But Taylor has no claim to enforce a duty owed to another. Taylor cannot
invoke a duty owed to Harrison to recover damages from lSI.
Taylor is not alleging that lSI breached a duty to warn her or her husband, Fred
Taylor, nor could she. Any theoretical duty here is untenable. There are several steps
between lSI and Taylor. lSI manufactured the product, lSI sold the product to Harrison,
Harrison credentialed the doctor, and the doctor ultimately operated on Taylor's husband
using the product. Although different duties exist in that chain of events, none supports
this claim. First, a duty to Taylor from lSI does not pass through the doctor. As this
court has said, it is a well-established rule that "the duty of the manufacturer to warn of
dangers involved in use of a product is satisfied if he gives adequate warning to the
physician who prescribes it." Terhune v. A.H. Robins Co., 90 Wn.2d 9, 13, 577 P.2d 975(1978). The duty to warn runs to the physician, not the patient. Thus this cannot be the
basis for Taylor's claim against lSI.
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No. 92210-1
Madsen, J., dissenting
Second, a duty to Taylor from lSI does not pass through the hospital. Harrison's
potential liability to Taylor for credentialing Dr. Scott Bildsten does not save Taylor's
claim because Taylor has already settled all claims against Harrison. Taylor suggests that
she can bring this claim because lSI's failure to warn Harrison may have caused Harrison
to credential doctors it would not have otherwise, which in turn caused the ultimate injury
to her husband. But by rooting her claim in Harrison's credentialing, it appears that
Taylor is really seeking recovery from lSI for a claim that she has already settled with
Harrison. Seeking recovery from lSI for the failure of Harrison in credentialing its
doctors is also improper because hospitals owe a nondelegable duty to their patients. See
Douglas v. Freeman, 117 Wn.2d 242, 248, 814 P.2d 1160 (1991). Any duty that
Harrison owed to Taylor could not have been delegated to lSI. Thus this also cannot be
the basis for Taylor's claim against lSI. lSI simply owed no duty to warn-direct or
indirect-to Taylor.
Taylor cannot recover for an alleged breach of a duty that was owed to another.
She has no claim against lSI for a breach of its duty to Harrison. Because Harrison is not
a party to this case and thus cannot assert a claim against lSI, the trial court did not err by
not instructing the jury as to the duty that lSI owed Harrison. Even if the trial court
erroneously believed that no such duty existed, remanding this case would not suddenly
give Taylor a cause of action to invoke a duty owed to another.
Accordingly, I respectfully dissent.
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No. 92210-1
Madsen, .I., dissenting
4