Court Opinion

ID: 2815017
Source: CourtListenerOpinion
Date Created: 2015-07-07 20:34:47.119141+00
Date Added: 2024-06-11T12:12:21.184833
License: Public Domain

FILED
                                                                                                             CURT OP ,4PPEALS
         IN THE COURT OF APPEALS OF THE STATE OF WASHINGTON IS MIN Ii

                                                        DIVISION II                                      2015 JUL - 7 AM 8: 41

                                                                                                         S
JOSETTE                 TAYLOR,               as        Personal                     No. 45052 -6 -II
representative          of    the   Estate     of   FRED      E.                                         a

 TAYLOR, deceased; and on behalf of the Estate
    of   FRED      E.    TAYLOR;             and    JOSETTE

 TAYLOR, Individually,

                                          Appellant,

          V.

    INTUITIVE       SURGICAL,             INC.,     a    foreign           PUBLISHED IN PART OPINION

    corporation doing business in Washington,

          MELNICK, J. —             Josette    Taylor,     individually and in her capacity as the personal

representative of       the   estate of   her husband Fred E. Taylor,'        appeals from a jury verdict finding no

liability by    Intuitive Surgical, Inc. ( ISI)         under the Washington Tort Reform and Product Liability

Act ( WPLA),2 for Taylor' s injuries resulting from complications during a robotically assisted

prostatectomy.     3 Taylor argues that the trial court erred by not instructing the jury that ( 1) ISI,

manufacturer of the system used to perform the surgery, owed a duty to warn the hospital in

addition to the surgeon, and ( 2) strict liability governed the duty to warn. In the published portion

of this opinion, we hold that under the learned intermediary doctrine, ISI only had a duty to warn

    Josette Taylor was not involved in the events at issue. For the purpose of simplicity, we refer to
the appellants collectively as " Taylor," and we will refer to Fred Taylor individually as the same.
We intend no disrespect.

2 Chapter 7. 72 RCW.

3                                                                                        is
    A prostatectomy is            surgery in.which the
                              a                            patient'   s prostate gland        removed.
45052 -6 -II

the   surgeon and not    the hospital.      We further hold that a negligence standard governs the duty to

warn a learned intermediary about a medical product.

          Taylor further argues that the trial court abused its discretion by refusing to allow Taylor

to introduce   evidence of other      incidents concerning ISI'          s product.      In the unpublished portion of

this opinion, we hold that the trial court did not abuse its discretion by excluding Taylor' s evidence

of other incidents with ISI' s product. Accordingly, we affirm the trial court.4
                                                        FACTS

I.        BACKGROUND

          ISI designs,      manufactures,     and   markets       the   da Vinci System.       The da Vinci System

facilitates minimally invasive robotic surgery by allowing a surgeon to remotely operate very small

instruments that are inserted inside the patient' s body through incisions much smaller than those

used    in traditional (         patient)
                            open -           surgery.   The use of small incisions often results in shorter

                                                                    hospital              A robotic surgery may not,
recovery times, fewer         complications,     and reduced                    costs.

however,    remove as much cancer as an equivalent open procedure.
                                                                                          Despite these shortcomings,

the da Vinci System is now used in approximately 84 percent of prostatectomy surgeries in the

United States.

          The da Vinci System is a fairly new technology, having been used for the first time on

humans in 1997. In 2001, the Food and Drug Administration (FDA) cleared ISI to market the da

4 Taylor requests that we reach two additional assignments of error: challenges to the trial court
                                                                  failure to   mitigate.    Taylor concedes that the
instructing    the   jury   on   superseding    cause   and

challenged instructions do not constitute reversible error because the jury did not reach either issue.
However, Taylor requests that if we reverse the trial court and remand for a new trial, we address
the additional instructional challenges to avoid repetition of the trial court' s alleged errors on
remand.   Because we affirm the trial court, we do not reach Taylor' s additional assignments of
 error.

                                                              0
45052 -6 -II

Vinci System for prostatectomy surgery,                      finding     that the   da Vinci System         was "   substantially

equivalent" to devices that the FDA had cleared in the past.5 Clerk' s Papers ( CP) at 344; see

Federal Food,        Drug,      and    Cosmetic Act, § 510( k), 21 U.S. C. § 360( k).              The da Vinci System is

restricted "   to   sale   by   or on      the   order of a physician."    CP at 364.

         The da Vinci System is a highly complex medical device. While the learning curve varies

from surgeon to surgeon, ISI estimates that between 20 and 30 da Vinci System surgeries are

needed   before       a surgeon will             be   comfortable with    the   system.     Although ISI' s learning curve

estimation     is   consistent with some               scholarly   research, other researchers       believe that "[    s] urgeon

comfort and confidence" is not attained until a surgeon has performed between 150 and 250 robotic

procedures.         Report      of   Proceedings ( RP) ( May        1, 2013) at 1948.

         As part of their training, ISI requires surgeons who are just beginning with the da Vinci
System to      undergo either           two      proctored cases or an amount set         by   hospital   protocol.   Following

that, ISI requires surgeons to choose simple cases for their first four to six unproctored procedures

and   to " slowly     progress        in   case   complexity."     Supp. CP at 6029. During their first surgeries with

the da Vinci System, surgeons performing prostatectomies are advised to choose patients with a

                index ( BMI)                 less than 30    and no prior    history   of   lower   abdominal       surgery.   ISI
body   mass                            of

specifically warns surgeons not to use the da Vinci System if a patient exhibits " morbid obesity."
CP at 159. Furthermore, ISI recommends that da Vinci System operators place their patients in a

steep Trendelenburg position, which means an incline of greater than 20 degrees. This position is
recommended to make it easier for the surgeon to see what he or she is doing.

         Before a doctor may perform a procedure at a hospital or medical institution, he or she

must be credentialed by the institution. Each institution determines its own credentialing process.

 5 The training program for new operators of the da Vinci System is not FDA approved.

                                                                     3
45052 -6 -II

ISI recommends to hospitals that surgeons credentialed to use the da Vinci System " meet basic

and advanced       laparoscopic   requirements."'      CP at 5798.

11.       TAYLOR' S SURGERY

          Dr. Scott Bildsten, who performed Taylor' s surgery, took an early interest in the da Vinci

System. At the time of Taylor' s surgery, Dr. Bildsten had extensive experience in traditional open

surgery and had performed between 80 and 100 open prostatectomies. He also had experience in
performing hand -assisted laparoscopic procedures, meaning he operated with one hand outside of
the patient' s body.

          Dr. Bildsten received training from ISI and Harrison Medical Center credentialed him in

operating the da Vinci System.            As part of his training, Dr. Bildsten observed more than ten

surgeries involving the da Vinci System, and he performed two proctored surgeries using the da
Vinci System. Although the           proctored surgeries were "      fairly long," Dr. Bildsten thought he had

done " really well" and felt encouraged to continue using the da Vinci System. RP (Apr. 23, 2013)
 at   1067, 1071.    Dr. Bildsten denied that ISI ever pressured him into performing robotic surgery.

           In 2008, Dr. Bildsten treated Taylor for        prostate cancer.   They discussed various courses

 of   treatment,    but Taylor insisted   on a    prostatectomy.     They also discussed the possibility of a

 robotic procedure, and Dr. Bildsten advised Taylor that he was " just starting with the robotic

 technique."       RP ( Apr. 23, 2013)    at   1067.   Taylor agreed to start with a robotic surgery and to

 convert    to   an open procedure   in the   event of "any potential unsafe situations."   RP ( Apr. 23, 2013)

 at 1067.

 6 A laparoscopic procedure is any procedure in which the surgeon inserts tools through .small
 incisions.

                                                           2
45052 -6 -II

          By     Dr. Bildsten'    s own admission,         because          of   Taylor' s   morbid      obesity, 7   he was not an

optimal candidate for a prostatectomy. Dr. Bildsten understood that he should only operate on thin

patients while       he   was still new   to the    da Vinci System. Taylor had received numerous surgeries

in the   past,   including    three   abdominal surgeries.                He also suffered from " uncontrolled" diabetes,

coronary artery disease, hypertension, and high cholesterol. RP ( Apr. 24, 2013) at 1346. Doctors
prescribed cholesterol medications for Taylor, but he did not consistently take them.

          Nevertheless, in his first non -proctored surgery with the Da Vinci system, Dr. Bildsten

operated on Taylor. Dr. Bildsten could not put Taylor in the steep Trendelenburg position because

of   Taylor'   s"   abdominal girth."     CP   at   253.        As a result, Dr. Bildsten had no choice but to flatten

out   Taylor to      a slighter   incline,   which made           it difficult to       see what    he    was   doing "   due to the

                                                                              field."   CP        253.    After " several hours of
                           continually getting into the
intestinal     contents                                           visual                     at

trying   to get better     visualization,"   Dr. Bildsten gave up on the da Vinci System and converted the

procedure      to   an open     prostatectomy.      CP     at   253.       At some point during the open procedure, Dr.

Bildsten tore Taylor' s rectal wall with his finger. Fecal matter escaped Taylor' s rectum and caused

a blood infection.

          Taylor     remained     in the operating       room      for approximately 15 hours. He suffered various

complications from being under anesthesia for too long. He experienced a massive breakdown of

muscle and kidney failure because he was not moving and his blood was not circulating properly.

He also experienced brain swelling because his head was tilted down for an extended time during

surgery.

I
    Taylor   weighed      280   pounds and    had    a   BMI     of   approximately 39.           ISI advises beginner da Vinci
 System operators to choose patients with a BMI of less than 30.

                                                                      5
45052 -6 -II

                         the surgery, Taylor                      20 days in the intensive     care   unit.   He needed a
        Following                                      spent

                                           him breathe for                    this time.   Taylor had nerve and muscle
mechanical      ventilator     to   help                           much of

damage, which may have been                                 his                stay in the intensive   care unit.   He also
                                             caused    by         protracted

suffered a stroke during his stay in the intensive care unit.

III.    AFTERMATH

        Taylor' s quality of life diminished following his prostatectomy. He suffered weakness in
his shoulders, back, hip, and left arm; an atrophied right thigh; incontinence; and cognitive deficits
                   memory, depression,             and                    He needed a cane to walk most of the time.
including   poor                                            anxiety.

Losing his independence caused Taylor a great deal of frustration.
        Taylor died in 2012, four years after his prostatectomy. The cause of death was preexisting

 hypertensive     cardiovascular           disease."   RP ( May 6, 2013) at 2200- 01. The parties dispute whether

the prostatectomy hastened Taylor' s death.
                                                PROCEDURAL HISTORY

         Based on various legal theories, Taylor sued Dr. Bildsten, Dr. Bildsten' s partner and

medical practice,        Harrison Medical Center,              and    ISI.   In an amended complaint, Taylor dropped

Harrison Medical Center              as a   defendant.      Taylor also settled with the doctors and their medical

practice,   leaving      ISI   as   the only defendant for trial.              The trial court granted ISI' s summary

judgment       motion on all of       Taylor'    s claims, except         for the WPLA     claim.   Taylor does not assign

 error on appeal to this order granting summary judgment and dismissal.

         At trial, Taylor proposed jury instructions stating that ISI had a duty to warn not only Dr.
 Bildsten, but    also   Harrison Medical Center.                 The trial court declined to do so and instructed the

                                                                     31
45052 -6 -II

jury that ISI' s duty to adequately warn ran solely to Dr. Bildsten.8 Furthermore, the trial court
instructed the jury to apply a negligence standard in deciding ISI' s liability for failure to adequately
warn Dr. Bildsten. Taylor objected.

          The jury returned a verdict in favor of ISI, with 10 of the 12 jurors concluding that ISI was

not negligent in warning and training Dr. Bildsten. Taylor appeals.
                                                       ANALYSIS

I.        STANDARD OF REVIEW

          We review a jury instruction de novo if the challenge is based on a matter of law, or for
abuse of discretion if based on a matter of fact. Kappelman v. Lutz, 167 Wash. 2d 1, 6, 217 P.3d 286

 2009). "`     Jury instructions are sufficient if they allow the parties to argue their theories of the

case, do not mislead the jury and, when taken as a whole, properly inform the jury of the law to be
                                                                               825 ( 2005) (          quoting Hue v.
applied."'     Joyce    v.   Dep' t   of Corr., 155 Wash. 2d 306, 323, 119 P. 3d

Farmboy Spray Co., 127 Wash. 2d 67, 92, 896 P.2d 682 ( 1995)). Even if erroneous, a jury instruction

                                                     party. Anfinson        FedEx Ground Package Sys., Inc., 174
is   reversible error   only if it    prejudices a                     v.

Wn.2d 851, 860, 281 P.3d 289 ( 2012).

II.       LEARNED INTERMEDIARY DOCTRINE

          This case concerns the scope of a medical device manufacturer' s duty to provide adequate

warnings. In Washington, our learned intermediary doctrine treats manufacturers of prescription -

                                              from                     of other products.        McKee v. Am. Home
 only   medical products        differently           manufacturers

 Products,              113 Wash. 2d 701, 709, 782 P.2d 1045 ( 1989); Terhune                 v.   A. H. Robins Co., 90
               Corp.,

 Wn.2d 9, 12- 13, 577 P.2d 975 ( 1978).         The learned intermediary doctrine affects who must receive

 8 The court instructed the jury that a medical device manufacture' s duty is to adequately warn or
 instruct/train the patient' s doctor. For simplicity, we refer to the manufacture' s duty simply as the
 duty to warn.

                                                             7
45052 -6 -II

the   manufacturer' s              and   how the adequacy         of   the warning is to be   measured.   See Ruiz -
                        warning

Guzman     v.   Amvac Chem.     Corp.,   141 Wash. 2d 493, 506- 08, 7 P.3d 795 ( 2000); Rogers v. Miles Labs.,

Inc., 116 Wash. 2d 195, 197, 207, 802 P.2d 1346 ( 1991); Terhune, 90 Wash. 2d at 12- 13; McKee, 113
Wash. 2d at 709, 711. The doctor acts as a gatekeeper between the manufacturer and the patient. See

Terhune, 90 Wi. 2d       at   14; McKee, 113 Wash. 2d        at   711.    Therefore, both the challenged " failure -to -

warn instruction" and the challenged " negligence instruction" involve the same issue: whether the

learned intermediary doctrine is applicable in this situation.

          In the following analysis, we explain the learned intermediary doctrine and its underlying

policy    rationale.   We then apply the learned intermediary doctrine to the facts of this case and

reject Taylor' s challenges to the " failure -to -warn instruction" and the " negligence instruction."

          A.         WPLA Duty to Warn

          The WPLA preempts common law and governs all claims for product -related harm in

Washington.        Wash. Water Power Co.         v.   Graybar Elec. Co., 112 Wash. 2d 847, 851, 853, - 856, 774
P.2d 1199, 779 P.2d 697 ( 1989);       see   RCW 7. 72. 010( 4). Under the WPLA, a product manufacturer

is liable if a claimant' s harm is " proximately caused by the negligence of the manufacturer in that

the product was not reasonably safe as designed or not reasonably safe because adequate warnings

or    instructions   were not provided."       RCW 7. 72. 030( 1).        Warnings or instructions are inadequate

if.

          at the time of manufacture, the likelihood that the product would cause the
          claimant' s harm.or similar harms, and the seriousness of those harms, rendered the
          warnings or instructions of the manufacturer inadequate and the manufacturer could
          have provided the warnings or instructions which the claimant alleges would have
           been adequate.

RCW 7. 72. 030( l)( b).
45052 -6 -II

          Despite the use of the term " negligence" in the statute, a manufacturer' s failure to warn is

                                                         Macias         Saberhagen Holdings, Inc., 175 Wash. 2d 402,
generally       governed
                           by a strict liability test.             v.

409- 10, 282 P.3d 1069 ( 2012); Ayers          v.   Johnson & Johnson            Baby     Products Co., 117 Wash. 2d 747,

762- 63, 818 P.2d 1337 ( 1991).         This interpretation mirrors the rule of the RESTATEMENT ( SECOND)

OF   TORTS § 402A ( 1965),         which " embodies a doctrine of strict liability with respect to products

which are        introduced into the    stream of commerce."            Terhune, 90 Wash. 2d            at   12.   The standard is

strict   liability   because "    even where a product is faultlessly designed, it may be considered

unreasonably unsafe if it is placed in the hands of the ultimate consumer unaccompanied by
adequate                 of   dangers necessarily involved in its         use."      Terhune, 90 Wash. 2d at 12.
               warning

              Importantly, the Restatement makes an exception to the strict liability rule for products that
are " incapable of being made safe for their intended and ordinary use" but nevertheless are " fully
justified, notwithstanding the         unavoidable       high degree     of risk.
                                                                                    119
                                                                                          RESTATEMENT ( SECOND) § 402A

cmt.     k.    Prime examples of such products are " drugs, vaccines, and the like, many of which for

this very reason cannot legally be sold except to physicians, or under the prescription of a
physician."        RESTATEMENT ( SECOND) § 402A              curt.   k ( emphasis         added).   Similarly, the exception

applies to

              new or experimental drugs as to which, because of lack of time and opportunity for
              sufficient medical experience, there can be no assurance of safety, or perhaps even
              of purity of ingredients, but such experience as there is justifies the marketing and
              use of the drug notwithstanding a medically recognizable risk.

RESTATEMENT ( SECOND) § 402A cmt. k.

 9 ISI admits that the da Vinci System is an " unavoidably unsafe" product, as that term is used in
 RESTATEMENT ( SECOND) § 402A cmt. k. CP at 110.

                                                               E
45052 -6 -II

            Our Supreme Court                adopted   comment      k in Terhune, 90 Wash. 2d      at   14- 15,   and has

consistently held that it applied in cases involving medical products available only through a

physician, including WPLA actions. 10 Ruiz -Guzman, 141 Wash. 2d at 506- 08 ( citing Young v. Key
Pharms., Inc., 130 Wash. 2d 160, 167- 68, 922 P.2d 59 ( 1996) ( plurality                      opinion); Rogers, 116 Wash. 2d

at 197, 202- 04).

            B.       Who the Manufacturer Must Warn

            The WPLA does not expressly specify who must receive the manufacturer' s warnings. See

RCW 7. 72. 030 ( 1)( b), (         c) (   referring to warnings provided " with the product" and warnings issued
after a product was manufactured                  to " inform   product users").     However, the learned intermediary

doctrine directs that for certain medical products that are unavoidably unsafe, the " manufacturer' s

duty to warn of dangers associated with its product runs only to the physician; it is the physician' s
                                                       McKee, 113 Wash. 2d         at   709 (   emphasis added).    The reason
duty   to   warn    the   ultimate consumer."

for this doctrine is that when a medical product is available only by prescription (as is the da Vinci

System), the physician acts as a gatekeeper who stands in the place of the manufacturer in relation

to the   patient.    That is, the         physician acts as a "`   learned   intermediary"' who undertakes the duty to

  inform himself of the qualities and characteristics of those products which he prescribes for or

 administers to or uses on his patients, and to exercise an independent judgment, taking into account

his knowledge          of   the   patient as well as   the   product."    Terhune, 90 Wash. 2d at 14. The patient places

  primary        reliance"    on the physician' s informed judgment, rather than whatever warnings the

                                                     Terhune, 90 Wash. 2d at 14.           Therefore, the physician is in a
 manufacturer
                     may have included.

 to Taylor argues that the learned intermediary doctrine may excuse a manufacturer from the
 common law duty to warn a purchaser, but not the statutory duty to warn under RCW
 7. 72. 030( 1)( b).        But the WPLA preempts all common law products liability causes of action.
 Wash. Water Power Co., 112 Wash. 2d                      at   853, 856.    This preemption means that there is only one
 duty to warn in products liability law. We address that duty in the foregoing analysis.

                                                                   10
45052 -6 -II

superior position to warn the patient and the courts should not interfere with the physician -patient

relationship.

         Taylor argues that IS I' s duty to warn also runs to Harrison Medical Center as the purchaser

of the da Vinci System and that the learned intermediary doctrine is inapplicable here; i.e, the

doctrine has no bearing on whether ISI has a duty to warn Harrison Medical Center. We disagree.
         The fact that Harrison Medical Center purchased the product rather than Taylor arguably

distinguishes our Supreme Court' s medical products cases, where the patient actually purchased

the   product at      issue.        See,   e. g.,   Terhune, 90 Wash. 2d at 10- 11 ( intrauterine contraceptive device);

McKee, 113 Wash. 2d               at   703- 04 ( prescription           drug); Rogers, 116 Wash. 2d at 198- 99 ( blood products

                                                                130 Wash. 2d 162- 63 (   prescription   drug).   However, this
administered         intravenously); Young,                                    at

distinction is immaterial because the da Vinci System was used on Taylor and he suffered the harm

caused by that surgery. The learned intermediary doctrine is not concerned with who pays for the
product or who retains possession of the product. Rather, its rationale is based on the physician' s

role as gatekeeper who stands in the place of the manufacturer in relation to the patient to provide

                                                           products accessible                by   prescription.   Here, Dr. Bildsten
warnings about         unavoidably            unsafe                                   only

acted    as    the    gatekeeper;          i. e. the learned intermediary similar to the doctors who acted as

 gatekeepers in Terhune, McKee, Rogers, and Young.

          The dissent would hold that the learned intermediary doctrine does not apply to ISI' s duty

 to warn Harrison Medical Center.                          The dissent' s analysis is premised on the idea that ISI had a

 duty to warn Harrison Medical Center about the da Vinci System because Harrison Medical Center
 purchased      the   product.        Dissent       at   2 ("   1 would hold that the learned intermediary doctrine does not

 remove a manufacturer' s duty to warn a hospital about medical equipment purchased by that
 hospital.").        We disagree with the dissent that the learned intermediary doctrine operates by

                                                                          11
45052 -6 -II

removing     a manufacturer' s   duty   to   warn.   Rather, we understand the doctrine as directing that

manufacturers of "unavoidably unsafe products" satisfy their duties under the WPLA by providing

warnings solely to learned intermediaries.

        We now address Taylor' s instructional challenges.

        C.       Harrison Medical Center Is Not a Second Learned Intermediary

        Taylor argues that the trial court erred by failing to instruct the jury that ISI had a duty to

warn   Harrison Medical Center.         ISI argues that the court correctly instructed the jury that ISI' s

duty to warn ran only to Dr. Bildsten. We agree with ISI and affirm the trial court.
        No one disputes that as the prescribing physician, Dr. Bildsten is a learned intermediary.

Further, no one disputes that under the learned intermediary doctrine, ISI had a duty to provide

warnings to Dr. Bildsten. The issue Taylor raised is, if the learned intermediary doctrine applies,

whether the hospital acted as a second learned intermediary, meaning that ISI also had a duty to

provide warnings to Harrison Medical Center.

         We review this question of first impression in Washington by reviewing the policies behind

the learned    intermediary   doctrine    as noted above.     Those policies convince us that the hospital

 does not share in the physician' s role as a learned intermediary. The learned intermediary doctrine

 singles out the physician " because it is he who finally controls the dispensing of the product."
 Terhune, 90 Wash. 2d at 16. Here, Dr. Bildsten held final control over the use of the da Vinci System.

 Dr. Bildsten examined Taylor, took his individualized circumstances into account, discussed

 several potential courses of treatment with Taylor, warned him of the risks, and made the ultimate

 decision to employ the da Vinci System.

         Taylor argues that if Harrison Medical Center had not purchased the da Vinci System,

 Taylor would not have received a da Vinci System surgery. But a third party that facilitates the

                                                         12
45052 -6 -II

distribution of a medical product, yet does not exercise its own individualized medical judgment,

is   not a   learned     intermediary. In McKee, our Supreme Court considering a closely related issue

held that a pharmacist owed no duty to warn the patient -because

             n] either manufacturer nor pharmacist has the medical education or knowledge of
             the medical history of the patient which would justify a judicial imposition of a
             duty   to intrude into the               patient
                                            physician -         relationship.   In deciding whether to use
             a prescription drug, the patient relies primarily on the expertise and judgment of the
             physician....      Requiring the pharmacist to warn of potential risks associated with
             a drug would interject the pharmacist into the physician -patient relationship and
             interfere   with   ongoing treatment.        We believe that duty, and any liability arising
             therefrom, is best left with the physician.
113 Wash. 2d at 711- 712.

             Like    the    pharmacist      in   McKee,    Harrison Medical      Center did not take Taylor' s

individualized circumstances or medical history into account. Nothing in the record indicates that

Harrison Medical Center played any role in deciding whether Taylor should receive a da Vinci
System surgery.             Harrison Medical Center did not and could not exercise independent medical

judgment in Taylor' s specific case. It merely made the da Vinci System available for physicians,

like Dr. Bildsten, and credentialed them. But as McKee demonstrates, a party that simply enables

a medical product to get to a patient does not share the special type of relationship with the patient

as does the prescribing physician.

             Our Supreme Court' s policy of deferring to the physician -patient relationship applies in
                                                                      711- 12; Terhune, 90 Wash. 2d 14- 15.   Dr.
                                        g., McKee, 113 Wn.2d
                                                                                                   at
 full to this       case.   See,   e.                            at

 Bildsten, the prescribing physician, bore the ultimate decision- making responsibility, and under

 the learned intermediary doctrine ISI fully complied with its duty to warn by warning Dr. Bildsten.
 We reject Taylor' s invitation to extend the learned intermediary rule to a hospital that does not

 exercise patient -specific medical judgment. The trial court did not err by instructing the jury that

                                                                13
45052 -6 -II

ISI'   s   duty   to   warn ran     to Dr. Bildsten.     And the trial court did not err by refusing to instruct the

jury that ISI' s duty to warn also ran to Harrison Medical Center.
            D.          Standard of Liability for Duty to, Warn

                         established who must receive warnings ( the physician),            we now turn to what kind
            Having

of   warning       must      be    given.    Taylor argues that the trial court improperly applied a negligence

standard      based     on   its   erroneous application of comment           k to the RESTATEMENT ( SECOND) § 402A.

Taylor argues that the proper standard for its failure -to -warn claim is strict liability. We disagree

and hold that a negligence standard governs the duty to warn a learned intermediary about a

medical product.

             In Rogers, our Supreme Court held that comment k applies to blood and blood products,

and that a manufacturer of such products is " liable in negligence and not in strict liability" if it

fails to      provide        adequate       warnings. 116 Wash. 2d      at   207.   This rule came about because a

manufacturer of an unavoidably unsafe product is liable for failure to warn only if it knew or should
have known of the defect. Rogers, 116 Wash. 2d at 207 ( citing Brown v. Superior Court, 44 Cal. 3d
1049, 1059, 751 P.2d 470, 245 Cal. Rptr. 412 ( 1988)).                       This knowledge   requirement   is " an idea

which ` rings           of negligence."'         Rogers, 116 Wash. 2d at 207 ( internal quotation marks omitted)

 quoting Brown, 44 Cal. 3d at 1059).

             Here, Taylor alleges that ISI failed to warn physicians of dangers that it knew or should

 have known about based on both the medical literature and the studies that indicate the da Vinci

 System has a high learning curve. Like the failure -to -warn issue in Rogers, this question " rings of
116 Wash. 2d      at   207 ( internal   quotation marks omitted) ( citation omitted).   Therefore,
 negligence."

 whether ISI failed to warn physicians of known dangers raises an issue of negligence. Rogers, 116
Wash. 2d at 207.

                                                                    14
45052 -6 -II

         Taylor argues that Rogers is distinguishable and the da Vinci System is not entitled to the

blanket exemption from strict liability for medical products that the Court acknowledged in Ruiz -

Guzman, 141 Wash. 2d         at   511.   Rather, Taylor argues that the da Vinci System should be treated like

a pesticide, and the applicability of comment k should be conditioned on a factual analysis of

whether the product' s value to society exceeds the harm it causes. See Ruiz -Guzman, 141 Wash. 2d

at 511 ( rejecting a blanket application of comment k to pesticides and opting instead for a product -

by -product    approach).      Taylor' s argument is unsupported by any Washington authority.

         The presence of the physician as learned intermediary places medical products in a class

of their own, and justifies the " blanket exemption" referenced in Ruiz -Guzman. 141 Wash. 2d at 511,

508- 09. Unlike the pesticide in Ruiz -Guzman, the da Vinci System is a prescription product with

                                                      This fact is    relevant   because in     a strict   liability   case, "   the
access   strictly   controlled   by   a physician.'

reason why the warning was not issued is irrelevant, and the manufacturer is liable even if it neither
                                            the defect."   Brown, 44 Cal. 3d 1059   n. 4.   That is, ordinarily a
knew   nor could      have known       of                                           at

manufacturer' s failure to warn will never be reasonable, and thus strict liability is warranted. But

when the manufacturer is required to utilize a trained, credentialed physician to get the product to

the consumer, the reason why a manufacturer fails to give a warning becomes relevant.

         With medical products, the risks depend as much on the patient' s individual circumstances,

 as assessed by a qualified physician, as the qualities of the product itself. The manufacturer has
 no way of knowing at the outset what an individual patient' s needs will be. A manufacturer may
 reasonably choose to defer to the treating physician' s medical judgment rather than attempting to
                                                                      individual                           Hence, the blanket
 impose blanket       warnings    that may      not   apply in   an                patient' s case.

 exemption     for   medical products        discussed in Ruiz -Guzman           makes sense.       The trial court did not

 err by instructing the jury on the negligence standard. .

                                                                 15
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         D.       Conclusion

         We hold that the court properly instructed the jury with the " duty -to -warn" and negligence

instructions under the learned intermediary doctrine, as articulated in controlling medical products .

cases. Accordingly, we affirm.

         A majority of the panel has determined that the remainder of this opinion lacks precedential
value and will not be printed in the Washington Appellate Reports. The remainder of this opinion

will be filed for public record in accord with RCW 2. 06. 040, it is so ordered.

I.       EVIDENCE OF OTHER INCIDENTS

         Taylor argues that the trial court abused its discretion when it excluded Taylor' s rebuttal

                                                     of   Harrison Medical Center'    s   robotics   program.   ISI
evidence      concerning the     overall   success

         that the   court              excluded   this    rebuttal evidence under   ER 403.    ISI further argues
argues                      properly

that the trial court' s curative instruction mitigated any prejudice to Taylor. We agree with ISI.

         A.         Additional Facts

         Before trial on Taylor' s WPLA claim, Taylor moved to exclude evidence " related to the

absence of subsequent injuries, accidents, or bad outcomes at the hands of surgeons other than Dr.

 Scott Bildsten     at   Harrison Medical Center using the da Vinci       robot."   CP at 2626. The trial court

reserved its ruling.

         During Taylor' s recross -examination, he asked ISI representative Sean O' Connor whether
 he had expressed doubts about the quality of the da Vinci System program at Harrison Medical

 Center. O' Connor said that he had not. When Taylor asked why, O' Connor responded that:

          outside of this incident we' re talking about, [ the da Vinci System has] been a very
          successful program. The surgeons that were involved from the beginning are still
          involved       today. The hospital made the decision to buy [ ISI] technology this past
          December. They' re currently talking to our clinical team to buy another one. These
          are all the same doctors that were involved in 2008 minus Dr. Bildsten. So if they

                                                             16
45052 -6 -II

          were concerned about the quality the technology was providing to the patient care,
          they wouldn' t be reinvesting in the program.

RP ( Apr. 22, 2013) at 855.

          Taylor requested a sidebar and argued that O' Connor' s testimony improperly implied that

Taylor' s surgery was " the only incident with the da Vinci" and, thus, opened the door to evidence
of other mishaps with         the   da Vinci System.   RP ( Apr. 24, 2013)   at   1229- 30.   As such, Taylor

offered proposed exhibit 304, a record of the first 233 robotic procedures at Harrison Medical

Center.

          The trial court refused to admit exhibit 304, ruling that it had " very little probative value"

because there was " no indication of who the surgeons were, their experience, patient outcomes,"

and " no comparison of complication rates with nonrobotic
                                                          surgeries."             RP ( Apr. 29, 2013) at 1428.

But the court did read a curative instruction to the jury stating:

          Each side has its own view as to whether there were other incidents at Harrison
           Medical Center] after Mr. Taylor' s incident. I have ruled that neither side should
          present that evidence, and accordingly, I am instructing you to disregard Mr.
          O' Connor' s testimony regarding whether or not there were other incidents in the
          Harrison [ Medical Center] da Vinci program.,

CP at 4693.

          B.        Trial Court' s Ruling

          We review an evidentiary challenge for abuse of discretion. Kappelman, 167 Wash. 2d at 6.

 Similarly, a trial court has considerable discretion regarding whether the door is opened to a line
 of   inquiry.   Burchfiel   v.   Boeing Corp., 149 Wash. App. 468, 490, 205 P.3d 145 ( 2009).

          Here, Taylor sought to introduce evidence concerning 233 other surgeries utilizing the da

 Vinci System. The court disagreed, pointing out that:

                    Aside from the other issues of hearsay and the business records, we don' t
           have the ability and I' m not going to open the case up to inquire of the other
           surgeries, were the complications actual complications, were they really bad, some

                                                         17
45052 -6 -II

         sound bad, or were they minor, were they typical things that occur during the course
         of regular surgeries.

                Each side indicates if we were to get involved in this, it would be necessary
         to question the doctors who performed the surgeries listed in the complications
         chart.

RP ( Apr. 29, 2013)          at   1428- 29.    For these reasons, the court ruled that " the admission of this

evidence would           be confusing   and prejudicial."        RP ( Apr. 29, 2013) at 1429.

          Here, the        specific   circumstances      of   Taylor'     s    da Vinci System surgery— including            his

preexisting conditions, his suitability for a robotic prostatectomy, and the particular procedure Dr.
Bildsten used in conducting the surgery— were                   crucial to the case. In contrast, Taylor did not (and

could not reasonably) offer details regarding the 233 other surgeries. But without this context, the
jury could not reasonably compare Taylor' s outcome to the outcomes in other surgeries involving
the da Vinci System. If O' Connor' s testimony improperly invited the jury to consider the da Vinci
 System outside the specific context of Taylor' s case, the proper remedy was not to exacerbate the

 error by introducing more evidence of outside matters. Rather, the proper remedy was to admonish
                    to   consider other     incidents,   as   the trial   court          did.   The trial court did not abuse its
 the   jury   not

 discretion, and we affirm.

                                                                                    kl
                                                                              I - -- _
                                                                                                  a

                                                                                                      2..
                                                                                                       zW        a

                                                                                         Melnick, J.

 I concur:

                                        r

              Sutton, J.

                                                                  18
45052 -6 -II

         Worswick, P. J., (    dissenting   in   part) —   I agree with the majority that the trial court

properly instructed the jury to apply a negligence standard to Fred E. Taylor' s inadequate
warning claims. In addition, I agree that the trial court did not abuse its discretion when it
excluded rebuttal evidence concerning the overall success of Harrison Medical Center' s robotics
                                                                                                          11
program.     But I disagree    with   the majority'   s conclusion   that the " learned   intermediary"

doctrine applies to Intuitive Surgical Inc.' s ( ISI) duty to warn Harrison.

         While it is true that the rationale behind the learned intermediary doctrine is that the

physician serves the role of a gatekeeper, I would hold that the physician serves this gatekeeper

role only where the physician stands between a manufacturer and the person who the
manufacturer failed to warn.

         Because physicians are gatekeepers between manufacturers and unwarned patients, the

physician protects the unwarned patients. Thus, the learned intermediary doctrine serves to

remove a manufacturer' s duty to warn the patient. But because the physician does not stand
between manufacturers and unwarned hospitals, the physician does not protect the unwarned

hospital. Thus, the learned intermediary doctrine does not remove a manufacturer' s duty to warn
hospitals about medical equipment purchased by that hospital. Because sufficient evidence

 supports Taylor' s theory that ISI' s negligent failure to warn Harrison caused Taylor' s harm, I
 would hold that the trial court erred by failing to give an instruction on whether ISI negligently

 failed to warn Harrison and thereby caused Taylor' s harm.

 ii
      Terhune   v.   A. H. Robins Co., 90 Wash. 2d 9, 14, 577 P.2d 975 ( 1978) ( internal quotation marks
 omitted).

                                                             19
45052 -6 -II

                                        I. LEARNED INTERMEDIARY DOCTRINE

        I would hold that the learned intermediary doctrine does not remove a manufacturer' s

duty to warn a hospital about medical equipment purchased by that hospital. In Terhune v. A.H.
Robins Co.,     our Supreme Court held that under the learned intermediary doctrine, the

manufacturer has no duty to warn a physician' s patient because the physician stands as a

 learned intermediary" between the manufacturer and the unwarned patient. 90 Wash. 2d 9, 14,
577 P.2d 975 ( 1978) ( internal         quotation marks omitted).            The court explained its reasoning for

applying the learned intermediary doctrine:

        Where a product is available only on prescription or through the services of a
        physician, the physician acts as a " learned intermediary" between' the manufacturer
        or seller and the patient. It is his duty to inform himself of the qualities and
        characteristics of those products which he prescribes for or administers to or uses
        on his patients, and to exercise an independent judgment, taking into account his
        knowledge        of   the    patient as well as     the   product.    The patient is expected to and, it
                be                   does   place             reliance upon     that judgment.      The physician
         can         presumed,                      primary
         decides      what    facts   should   be   told to the patient.       Thus, if the product is properly
         labeled and carries the necessary instructions and warnings to fully apprise the
         physician       of    the    proper     procedures       for   use   and   the   dangers   involved,   the

         manufacturer may reasonably assume that the physician will exercise the informed
        judgment thereby gained in conjunction with his own independent learning, in the
         best interest of the          patient.      It has also been suggested that the rule is made
         necessary by the fact that it is ordinarily difficult for the manufacturer to
         communicate directly with the consumer.
90 Wash. 2d      at   14 ( emphasis     added) (   footnote   omitted).     Thus, a properly warned physician is a

learned intermediary between the manufacturer and the unwarned patient because by using
 independent judgment to determine which medical products a patient should receive and what

 information a patient needs to know about those medical products, the physician serves as a

 gatekeeper between the manufacturer and the unwarned patient.

         In McKee v. American Home Products Corp., the court held that pharmacists have no

 duty to warn patients because physicians, not pharmacists, serve as the gatekeepers between the

                                                                  20
45052 -6 -II

manufacturer and     the   unwarned patient.   113 Wash. 2d 701, 711- 12, 782 P.2d 1045 ( 1989). This is

because it is physicians, not pharmacists, who exercise independent judgment to determine

which medical products a patient should receive and what information a patient needs to know

about those products. See 113 Wash. 2d at 711- 12.

        While a physician is the gatekeeper between the manufacturer and the unwarned patient,

a physician is not a gatekeeper between the manufacturer and the unwarned hospital because the

physician does not use independent judgment to determine which medical products a hospital

should receive and what information a hospital needs to know about those products. Rather, the

hospital exercises independent judgment to determine which medical products it should purchase

and receives information about those products directly from the manufacturer. Furthermore, _

unlike in the situation of a patient, it is not difficult for the manufacturer to communicate directly

with the hospital.

         This case illustrates why the learned intermediary doctrine should not apply to a

manufacturer' s failure to warn a hospital that has purchased a medical product. Here, Harrison

purchased the " da Vinci System" and was responsible for credentialing physicians to use it.

Clerk' s Papers at 344. This required exercising independent judgment to determine which

physicians had sufficient experience in laparoscopic surgery to use the da Vinci System, the

amount and nature of training required of these physicians, and the number of proctored da Vinci
 System surgeries required of these physicians. ISI had influence over Harrison' s independent

 determinations: three ISI employees sat on the steering committee that designed Harrison' s

 credentialing requirements. These independent determinations by Harrison could affect the

 quality of the physicians' use of the da Vinci System, which could affect the patients. Therefore,
 ISI' s failure to warn Harrison could harm Harrison, the physicians, and the patients. I would

                                                      21
45052 -6 -II

hold that because the physician is not a learned intermediary between manufacturers and

hospitals, the learned intermediary doctrine does not apply to a manufacturer' s failure to warn a
hospital that purchased a medical product.

                           II. INSTRUCTION ON FAILURE TO WARN HARRISON

         I would hold that the trial court erred by failing to give an instruction on whether ISI

negligently failed to warn Harrison and thereby caused Taylor' s harm. A trial court is obligated
to provide a jury instruction on any theory of the case that is supported by substantial evidence.

Kelsey   v.   Pollock, 59 Wash. 2d 796, 798, 370 P.2d 598 ( 1962); Estate ofDormaier v. Columbia

Basin Anesthesia, PLLC, 177 Wash. 828, 851, 313 P.3d 431 ( 2013).        Substantial evidence is a
                                            App.

  sufficient quantum to persuade a fair-minded, rational person of the truth of a declared

premise."'      177 Wn.   App.   at   851 ( quoting Helman        v.   Sacred Heart   Hosp., 62 Wash. 2d 136, 147,

381 P.2d 605 ( 1963)).     This      requires more   than   speculation and conjecture. 177 Wash. App. at

852. An instructional error is not harmless if it prevents a party from arguing his or her theory of

the   case.    Chunyk &   Conley/Quad-C v. Bray, 156 Wash. App. 246, 255, 232 P.3d 564 ( 2010).
          One of Taylor' s theories of the case was that ISI' s negligent failure to warn Harrison led

 Harrison to allow Dr. Scott Bildsten to use the da Vinci System on Taylor unsupervised despite

 Dr. Bildsten' s inexperience, thus causing harm to Taylor. This theory was supported by

 testimony that ( 1) no physician at Harrison had any significant knowledge about the da Vinci
 System; ( 2)    the medical research supported that physicians needed up to 250 surgeries with the

 da Vinci System to be      comfortable with       it; (3) after ISI gave Harrison information suggesting

 that two proctored surgeries was sufficient, Harrison required physicians to perform only two

 proctored surgeries; (   4) Dr. Bildsten used the da Vinci System unsupervised on Taylor after only

 two   proctored surgeries; (    5) Dr. Bildsten needed far more than two proctored surgeries before

                                                             22
45052 -6 -II

safely operating the da Vinci System unsupervised; and ( 6) use of the da Vinci System
contributed to Taylor' s harm. This is substantial evidence to support that ISI' s negligent failure

to warn Harrison led Harrison to allow Dr. Bildsten to use the. da Vinci System on Taylor

unsupervised despite Dr. Bildsten' s inexperience, thereby causing harm to Taylor.

        Allowing the learned intermediary doctrine to shield manufacturers in this instance
creates an environment that encourages manufacturers to refrain from disclosing dangers or

defects to the actual purchaser of the medical equipment. This skews the doctrine' s purpose.

        I would hold that the learned intermediary doctrine did not apply to eliminate ISI' s duty

to warn Harrison about the da Vinci System purchased by Harrison. Because sufficient evidence

supports Taylor' s theory that ISI' s negligent failure to warn Harrison caused Taylor' s harm, I
would hold that the trial court erred by failing to give an instruction on that theory. Therefore, I

respectfully dissent in part.

                                                                   rswick,   P. J.

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