Taylor v. Intuitive Surgical Inc.

Opinion

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 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

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

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

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

recommends that surgeons choose "simple cases" for initial unproctored

procedures. Clerk's Papers (CP) at 6029. lSI provided a user's manual to

doctors, containing various warnings related to the device. Three warnings are

particularly relevant to this case. First, as part of its training, lSI advised

surgeons not to perform prostatectomies on obese persons. lSI provided body

mass index (BMI) guidelines stating patients should have a BMI of less than

30. Second, lSI advised not to perform prostate procedures on persons who

previously underwent lower abdominal surgeries. Third, lSI warned that it was

unsafe for the patient not to be in a steep Trendelenburg position (tilted with

head downward) during the procedure.

Dr. Scott Bildsten had 15 years of experience performing open

prostatectomies, having performed between 80 and 100 such procedures prior

to Fred Taylor's surgery. He was also experienced with hand-assisted

laparoscopic procedures, in which the surgeon operates with one hand outside

of the patient's body and the other hand assisting the instruments inside of the

body. Dr. Bildsten had performed two proctored prostatectomies before

performing his first unproctored procedure on Taylor.

After receiving informed consent, Dr. Bildsten performed a robotic

prostatectomy on Taylor to treat his prostate cancer using the da Vinci System

on September 9, 2008. At the time of surgery, Taylor weighed 280 pounds and

4 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.

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

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.

6 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.

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

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?

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

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

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

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.

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

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

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

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

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

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.

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

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.

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

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.

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

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

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

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

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

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

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

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

19 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

20 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

21 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

22 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).

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

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

24 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."

25 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.

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

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.

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

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

28 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

29 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.

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

WE CONCUR:

(~/Q /

31 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 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.

2 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.

3 No. 92210-1 Madsen, .I., dissenting