JOSETTE TAYLOR, as Personal Representative of the Estate of FRED E. TAYLOR, deceased; and on behalf of the Estate of FRED E. TAYLOR; and JOSETTE TAYLOR, individually, Petitioner,
INTUITIVE SURGICAL, INC., a foreign corporation doing business in Washington, Respondent.
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 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.
Surgical Inc. (ISI) is the manufacturer of a robotic surgical
device called the "da Vinci System, " which
surgeons use to perform laparoscopic surgeries. ISI
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 than alternative methods.
Presently, the da Vinci System is used in about 84 percent of
prostatectomies in the United States.
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.
of its training, ISI 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). ISI recommends that
surgeons choose "simple cases" for initial
unproctored procedures. Clerk's Papers (CP) at 6029. ISI
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, ISI advised surgeons not to perform prostatectomies
on obese persons. ISI provided body mass index (BMI)
guidelines stating patients should have a BMI of less than
30. Second, ISI advised not to perform prostate procedures on
persons who previously underwent lower abdominal surgeries.
Third, ISI warned that it was unsafe for the patient not to
be in a steep Trendelenburg position (tilted with head
downward) during the procedure.
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.
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 had a BMI of 39
(contrary to ISI's advice to choose a patient with a BMI
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 ISI'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
ISI'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.
Id. at 1063.
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
after the surgery, Taylor filed suit against Dr. Bildsten,
his partner (Dr. John Hedges), their medical practice, and
Harrison Medical Center. He later added ISI. After he died,
his wife, Josette Taylor, proceeded with the lawsuit as
personal representative of his estate. Before trial,
Taylor settled with Drs. Bildsten and Hedges,
their private practice, and Harrison Medical Center. ISI was
the only remaining defendant. Taylor proceeded against ISI
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 ISI on all claims, except for Taylor's failure to warn
claim under the WPLA.
trial, ISI presented expert testimony that described the ISI
training process. Dr. Joel Lilly, a urologist with
significant robotic surgical experience, discussed the ISI
training course. ISI 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.
jury returned a verdict in favor of ISI. It found
specifically that ISI 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 ISI
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 ISI 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 standard 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 ISI'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. Taylor, 188 Wn.App. at 780 n.4. Here, Taylor
seeks review of these assignments of error. We granted
review. Taylor v. Intuitive Surgical, Inc., 184
Wn.2d 1033, 379 P.3d 957 (2016).
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 ISI.
ISI have a duty to warn Harrison Medical Center as the
purchasing hospital of the da Vinci System?
the trial court properly apply a negligence standard, as
opposed to strict liability, to Taylor's inadequate
the trial court err when it excluded Taylor's proposed
rebuttal evidence to testimony that Harrison Medical
Center's robotics program was successful overall?
the trial court err by instructing the jury on superseding
cause or failure to mitigate?
claims the trial court erred in four ways. First, Taylor
claims the trial court erred by not instructing the jury on
ISI'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
ISI'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 ISI'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.
Manufacturers Have a Duty To Warn Hospitals That Purchase
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 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
Manufacturers Have a Duty under the WPLA To Warn Purchasing
Hospitals of Product Dangers with the Product
reasons explained below, we find that the WPLA provides a
statutory duty that manufacturers must warn purchasers of its
dangerous products. 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 ISI have a duty
to provide warnings to the purchaser of the product-in this
case, Harrison Medical Center.
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.
WPLA was enacted in 1981 and closely mirrors the
Restatement (Second) of Torts § 402A (Am. Law.
Inst. 1965), which we adopted in a series of cases prior to
the enactment of the WPLA. See LAWS OF 1981, ch. 27;
Terhune v. AM. 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.
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 ...