Court Opinion

ID: 4706684
Source: CourtListenerOpinion
Date Created: 2021-07-27 06:44:46.330635+00
Date Added: 2024-06-11T08:06:36.939848
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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.
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       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.
       No. 92210-1

               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 v. Intuitive Surgical, Inc.
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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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       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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       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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       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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       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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       Taylor v. Intuitive Surgical, Inc.
       No. 92210-1

        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.
       No. 92210-1

       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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       Taylor v. Intuitive Surgical, Inc.
       No. 92210-1

        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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       Taylor v. Intuitive Surgical, Inc.
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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.
       No. 92210-1

        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:

        (~/Q
                                     /

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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