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IN THE SUPREME COURT OF THE STATE OF WASHINGTON JOSETTE TAYLOR, as Personal Represe- ) sentative ofthe Estate ofFRED E. TAYLOR,) deceased; and on behalfofthe Estate of ) FRED E. TAYLOR; and JOSETTE ) TAYLOR, individually, ) ) Petitioner, ) ) v. ) ) INTUITIVE SURGICAL, INC., a foreign ) corporation doing business in Washington, ) ) Respondent. ) 

# _____________________________) No. 92210-1 EnBanc
Filed 

## FEB 09 2017

OWENS, J.- Manufacturers have a duty to provide warnings to
consumers about the risks oftheirproducts pursuantto the Washingtonproduct liability act (WPLA), chapter 7.72 RCW. Inthis case, a manufacturer sold a surgical device to a hospital, which credentialed some ofits physicians to perform surgery with the device. The manufacturer's warnings regarding that device are at the heart ofthis case. We are asked to decide whether the manufacturer owed a duty to warn the hospital thatpurchased the device. TheTaylor v. Intuitive Surgical, Inc. No. 92210-1 manufacturer argues that since it warned the physician who performedthe surgery, it hadno duty to warn any other party. We disagree because the doctor is oftennotthe productpurchaser. We find that the WPLArequires manufacturers to warnpurchasers about their dangerous medical devices. Hospitals needthese warnings to credential the operating physicians and to provide optimal care for patients. Inthis case, the trial court did not instruct the jurythat the manufacturer had a duty to warn the hospital thatpurchasedthe 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 ofa robotic surgical device called the "daVinci 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 invasivebecause surgeons remotely operate onthe person by inserting the robotic instruments into the patientthrough small incisions. Since laparoscopic procedures use small incisions through the skin, the recovery times are much shorter and the surgeries result in fewer complications

2Taylor v. Intuitive Surgical, Inc. No. 92210-1 than alternative methods. Presently, the da Vinci System is used in about 84 percent ofprostatectomies in the United States. The daVinci System was used for the first time in 1997. In 2000, the United States Food and Drug Administration clearedthe daVinci System for certain surgeries, and it was cleared for prostatectomies in 2001. The da Vinci System is not used on a patient unless aphysician 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 ofthe "most complex medical devices" surgeons use. 11 Verbatim Report ofProceedings (VRP) (May 1, 2013) at 1912. Even with expertise in open surgery, a skilled surgeon would still need training and experience to operate the daVinci 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 ofits training, lSI requires that surgeons perform two proctored surgeries, but hospitals enforce their ownrequirements 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

3Taylor v. Intuitive Surgical, Inc. No. 92210-1 recommends that surgeons choose "simple cases" for initial unproctored procedures. Clerk's Papers (CP) at 6029. lSIprovided a user's manual to doctors, containing various warnings related to the device. Three warnings are particularly relevant to this case. First, as part ofits training, lSI advised surgeons not to perform prostatectomies on obese persons. lSIprovided body

mass index (BMI) guidelines stating patients shouldhave a BMI ofless than 30. Second, lSI advised not to performprostate procedures onpersons who previously underwent lower abdominal surgeries. Third, lSI warnedthat it was unsafe for the patient not to be in a steep Trendelenburg position (tilted with head downward) during the procedure. Dr. Scott Bildstenhad 15 years ofexperience performing open prostatectomies, having performed between 80 and 1 00 suchprocedures prior to Fred Taylor's surgery. He was also experienced withhand-assisted laparoscopic procedures, in whichthe surgeon operates with one hand outside ofthe patient's body and the other hand assisting the instruments inside ofthe body. Dr. Bildsten had performed two proctored prostatectomies before performing his first unproctored procedure on Taylor. Afterreceiving informed consent, Dr. Bildstenperformed a robotic prostatectomy on Taylor to treat his prostate cancer using the da Vinci System
on September 9, 2008. Atthe time ofsurgery, Taylor weighed 280 pounds and

4Taylor 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. Bildstentestified that he considered Taylorto be "severely obese." 7 VRP (Apr. 23, 2013) at 1140. Furthermore, Taylorhad threeprior 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 oflSI's advice to conduct the procedure in that position). Although Dr. Bildstenknew 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. Bildstenbecame
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 oflife 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.

5Taylor 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 HarrisonMedical Center. He later added 

### lSI. After he died, his wife, Josette Taylor, proceeded with the lawsuit as personal representative ofhis estate. Before trial, Taylor1 settled with Drs. Bildsten and Hedges, their private practice, and HarrisonMedical Center. 

### lSI was the only remaining defendant. Taylorproceeded against 

### lSI for claims ofproduct defect, breach ofwarranty, breach ofcontract, violation ofWashington's Consumer ProtectionAct (ch. 19.86 RCW), negligence, and product liability under the WPLA. The trial court granted summaryjudgment in favor of

### lSI on all claims, except for Taylor's failure to warn claim under the WPLA. Attrial, 

### lSI presented experttestimony that described the 

### lSI training process. Dr. Joel Lilly, a urologist with significantrobotic surgical experience, discussed the 

### lSI training course. 

### lSI trained surgeons on "howto selectyour best candidates for starting your experience," such as choosing "thinpatients" and those with no prior abdominal surgery. 14 VRP (May 7, 2013) at 2405. Dr. Lilly toldthejurythat in his opinion, Dr. Bildsten was negligent in performing Taylor's surgery.

1We refer to both plaintiffs, Fred and Josette Taylor, as "Taylor" for convenience. 6Taylor v. Intuitive Surgical, Inc. No. 92210-1 Thejuryreturned a verdict in favor oflSI. Itfound specificallythat lSI
was not negligent in providing warnings or instruction to Dr. Bildsten. Taylor appealed, raising several assignments oferror. First, Taylor claimedthat the trial court erred by declining to instruct thejurythat lSIhad a duty to warn Harrison Medical Center. The Court ofAppeals found by a 2-1 decision that the trial court did not err because lSI fulfilled its duty to warnbywarning Dr. Bildsten. Taylor v. Intuitive Surgical, Inc., 188 Wn. App. 776, 792,797-98, 355 P.3d 309 (2015) (published in part). Second, Taylor claimedthat the trial court erred by applying a negligence st.andard instead ofa strict liability standard. The Court ofAppeals unanimously found that the trial courtproperly applied a negligence standard to the inadequate warning claim. Id. at 794. Third, Taylor claimedthat 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. Inthe unpublished portion ofits opinion, the Court ofAppeals 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 challengedjury instructions on superseding cause and failure to mitigate. Since thejury did notreach these issues and the Court ofAppeals affirmed the trial court, it did notreach these additional assignments oferror.

7Taylor v. Intuitive Surgical, Inc. No. 92210-1 Taylor, 188 Wn. App. at 780 n.4. Here, Taylor seeks review ofthese assignments oferror. We grantedreview. 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 briefin support ofTaylor. 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 ofISI. ISSUES 1. DidlSI have a duty to warn HarrisonMedical Center as the purchasing hospital ofthe da Vinci System? 2. Didthe trial courtproperly 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 thejury on superseding cause or failure to mitigate?

8Taylor 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 thejury on lSI's duty to warn Harrison· Medical Center as the purchasing hospital. Second, Taylor claims the trial court erred in its application ofthe 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 thejury on superseding cause and failure to mitigate. As explained below, we find that the trial court erredbynot instructing thejury 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 onretrial. 1. Manufacturers Have aDuty To Warn Hospitals ThatPurchase MedicalProducts We find that the WPLA imposes a duty on manufacturers ofmedical products to warn hospitals ofthe products' dangers when they purchasethem. The manufacturer's duty to warnpurchasing hospitals is not excused when a manufacturer warns doctors who use the devices because hospitals need to know the dangers oftheir ownproducts, which cannot be accomplished simply

9Taylor 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 thejurythere was a duty to warn Harrison Medical Center ofthe da Vinci System's risks. A. Manufacturers Have aDuty under the WPLA To Warn PurchasingHospitals of ProductDangers with the Product For the reasons explained below, we find that the WPLA provides a statutory duty that manufacturers must warnpurchasers ofits dangerous products. 2 Although the duty is not explicitly stated in the text ofthe statute, the WPLA requires that warnings be provided withproducts. Since warnings must be provided "with" products, manufacturers like lSI have a duty to provide warnings to the purchaser ofthe product-inthis 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 theRestatement (Second) of Torts§ 402A (Am. Law. Inst. 1965), which we adopted in a series

2 lSI dedicated several pages ofits briefing to defend against a "dutyto 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. 10Taylor v. Intuitive Surgical, Inc. No. 92210-1 ofcases prior to the enactment ofthe 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. FordMotor 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 Restatementprinciples. Here, Taylor argues that the manufacturer's duty to warn exists in the plaintext ofthe WPLA. Taylor is correct. The WPLAprovides standards for product manufacturers and the basis for claims where "the claimant's harm was proximately caused by the negligence ofthe manufacturer in that the product
was notreasonably safe as designed or not reasonably safe because adequate warnings or instructions were not provided." RCW 7.72.030(1). A product is notreasonably safe due to inadequate warnings where the likelihood and seriousness ofthe harms the product could cause "renderedthe warnings or instructions ofthe manufacturer inadequate" and couldhave beenprovided. Id. at (1)(b). The WPLA does not specify who should receive these warnings. However, it states that "[a] product is notreasonably safe because adequate warnings or instructions were notprovided with theproduct
. ..." !d. (emphasis added). On one hand, the statute discusses inadequate warnings

11Taylor v. Intuitive Surgical, Inc. No. 92210-1 owed "withthe product" for products where at the time ofmanufacture, there
was a likelihood the product would cause the plaintiffsharm. 

### !d. Onthe other hand, it discusses that warnings provided afterthe product was manufactured be given to "productusers." Id. at (l)(c). Since the product is owned and maintainedbythe purchasing hospital, it follows from the text ofthe statute that the purchaser is owed product warnings with theproductitpurchases. Especiallyhere, where the product is an extremely complex and inherently dangerous medical device, it is logical that hospitals would need warnings. Wehaveheld that hospitals have an independent duty ofcare to their patients. Pedroza v. Bryant, 101 Wn.2d 226, 232-33, 677 P.2d 166 (1984). Bothparties recognize this. During summaryjudgment argument, lSI's counsel acknowledged that "HarrisonMedical Centerhad an independent, nondelegable duty to credential and to perform a due-diligence evaluation to determine whether Dr. Bildsten was competentto perform surgery withthe da Vinci [System] without supervision." VRP (Feb. 26, 2013) at 37. Although
wehaverecognized that hospitals do nothave a duty to intervene in the doctorpatientrelationship, Howell v. Spokane & InlandEmpireBloodBank, 114 Wn.2d 42, 55, 785 P.2d 815 (1990), hospitals are required bylaw to adopt credentialing requirements regarding staffing. See RCW70.41.230; WAC 246- 320-161; 42 C.F.R. § 422.204. Harrison Medical Centerhas a credentialing

12Taylor v. Intuitive Surgical, Inc. No. 92210-1
process and it cleared Dr. Bildstento use the da Vinci System for the prostatectomy here. Thus, it follows that hospitals needproduct warnings to design a credentialing process that will keep patients as safe as possible. The Washington State Hospital Association argues in its amicus briefin support oflSIthat the hospital is not in the bestpositionto determine what procedure should be performed. Br. ofAmicus Curiae Wash. State Hosp. Ass'n at 13. However,justbecause the physician is in the best positionto make a decision regarding apatient's treatment, the hospital is not completely absent from the process. InPedroza, we adopted the doctrine ofcorporate negligence to address negligence beyond that ofthe physician, to recognize the
onus onthe hospital itselffor the competency ofthe 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 positionto monitor and control physician performance." Id. at 231. In adopting that doctrine, we recognized the "public'sperception ofthe modern hospital as a multifaceted health care facility responsible for the quality ofmedical care and treatment rendered." !d. We reasoned that imposing the doctrine ofcorporate negligence on hospitals and requiring them to assume responsibility would provide "hospitals a financial incentive to insure the competency oftheir medical staffs." Id. at 232.

13Taylor v. Intuitive Surgical, Inc. No. 92210-1 Itis 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 ofcare for the benefit oftheir 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 standardthat the law requires by excusing manufacturers from the duty to provide them information about devices thatthey own. Knowing the risks of the da Vinci System is necessary in orderto 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 ownerneeds a copy as well. Itis inthe best interest ofall 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 ofproductusers, which is why it explains what makes a product unsafe. Itrequires warnings for these dangerous products in orderto make them safe. Thus, the manufacturer's duty to warn hospitals is embedded in the text ofthe WPLA itself. Priorto the adoption ofthe WPLA, we adopted the learned intermediary doctrine, which flowed from a commentto theRestatementthat discussed the interpretation ofproducts liability principles to dangerous medicalproducts. The applicability ofthat doctrine is discussed in the next section.

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

### B. The LearnedIntermediary Doctrine DoesNotApply to This Case Under the learned intermediary doctrine, manufacturers ofmedical products can satisfy their duty to warnpatients ofthe risks oftheir 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 betterpositionto communicate them to the patient. Inthis case, lSI contends that the manufacturer's duty to warnthe hospital, which buys the product, is similarly met byproviding 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 ofthe product. Hospitals cannot meettheir own duty to patients withoutknowing the risks ofthe dangerous medical products they own. 

### i. Backgroundon the LearnedIntermediaryDoctrine We have found that under the learned intermediary doctrine, the manufacturer satisfies its duty to warn the patient ofthe risks ofits product where it properly warns the prescribing physician. 

### Terhune, 90 Wn.2d at 14. We have explainedthe policy behindthe doctrine as follows: Where aproduct is available only onprescription orthrough the services ofa physician, the physician acts as a "learned intermediary" betweenthe manufacturer or seller and the patient. Itis his duty to inform himselfofthe qualities and characteristics ofthose products which he prescribes for or administers to or uses on his patients, and to exercise an independentjudgment, taking into account his knowledge ofthe patient as well as the product.
15Taylor v. Intuitive Surgical, Inc. No. 92210-1 The patient is expected to and, it can be presumed, does place primaryreliance upon thatjudgment. The physician decides what facts should be told to the patient. Thus, ifthe product is properly labeled and carries the necessary instructions and warnings to fully apprise the physician ofthe properprocedures for use and the dangers involved, the manufacturer may reasonably assume that the physician will exercise the informedjudgmentthereby gained in conjunction withhis own independent learning, in the best interest ofthe patient. 

### !d. (footnote omitted). Thus, although the manufacturerhas a duty to warn patients ofproduct risks, it can satisfy this duty by warning the doctor (the learned intermediary), who then takes on the responsibility ofcommunicating those warnings to the patient. 

### !d. at 17. Here, we are asked the novel question ofwhether the manufacturer's duty to warnthe hospital also canbe satisfied by warning the doctor. However,
as explained below, the doctor is not a learned intermediary betweenthe manufacturer and the hospital, and thus the doctrine does not apply here. ii. The LearnedIntermediary Doctrine DoesNotApply To Excuse the Mamifacturer's Duty To Warn the Purchasing Hospital As stated above, the learned intermediary doctrine's focus is onthe warnings to the patient and the doctrine releases the manufacturer's duty to
warnthe patientwhere it provides warnings to the learned intermediary physician. Here, lSI argues that a manufacturer need not warn any otherparty where it has warned the prescribing physician. As explained below, this argument fails because the manufacturer has an independent duty to warnthe
16Taylor v. Intuitive Surgical, Inc. No. 92210-1 purchaser ofthe product and becausephysicians do not function inthe same intermediary capacity between the manufacturer and purchaser. The dissentingjudge for the Court ofAppeals explained why the learned intermediary doctrine does not apply inthis case: the "doctrine does not remove
a manufacturer's duty to warnhospitals about medical equipmentpurchased by that hospital." Taylor, 188 Wn. App. at 795 (Worswick, J., dissenting in part). That duty to warn the purchaser is independent ofthe duty to warnthe patient. Thejudge explained, "While a physician is the gatekeeper betweenthe manufacturer and the unwarnedpatient, a physician is not a gatekeeperbetween the manufacturer and the unwarned hospital
. ..." Id. at 796 (Worswick, J., dissenting inpart). Hospitals have an independent duty to ensure a device is used safely. They canmeet that duty only ifthey are informed oftherisks of using a device. Physicians do not function as an intermediary with a duty to
warnthe hospital ofthe risks ofa device, so nothing about the learned intermediary doctrine applies here. Bothparties pointto one case for support, inwhichwerelied onthe learned intermediary doctrine to hold thatpharmacists do nothave a duty to
warn patients about prescription drugs theyprovide patients. McKee v. Am. Home Prods. Corp., 113 Wn.2d 701, 720, 782 P.2d 1045 (1989). However, McKee is nothelpful to this case. McKee presentedthe question ofwhetherthe

17Taylor 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. 

### I d. at 707. In that case, we compared the pharmacist to the manufacturer and found that the pharmacist did nothave to separately warn the patientbecause the doctor, as learned intermediary, had already done so. 

### Id. at 711. That analysis has no bearing herebecause this case involves a separate duty that flows from the manufacturerto the purchaser and is not about whether a learned intermediary cuts offthe duty to warnpatients. This doctrine should not serve to excuse the manufacturer's duties to
warn other entities to ensure the safety ofpersons its product willbeused on. Since the learned intermediary doctrine underscores the importance ofpatient safety, it wouldbeillogical ifthe doctrine was used to excuse another avenue to achieve that goal. Ifpatient safety is the goal, then itrequires all hands on deck. While doctors are recognized as the gatekeepersbetween the manufacturer and the patient, the hospital is the gatekeeperbetween the physician and the use ofthe da Vinci System since the hospital clears surgeons to use it. Thus, the hospital musthave 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 warnthe hospitalbecause it pertains to the

18Taylor v. Intuitive Surgical, Inc. No. 92210-1
manufacturer's duty to warn only the patient, notthe productpurchaser. Consequently, we find thatthe trial court erred by declining to give thejury an instruction onlSI's duty to warn Harrison Medical Center. Based onthat error,
we vacate the defense verdict and remand for retrial. To provide guidance to the parties onretrial, we address Taylor's other arguments below. 2. The StrictLiability Standard Governs Inadequate Warning Claims on Dangerous MedicalProducts Like the da Vinci System Taylor argues thatthe trial court erredby applying a negligence standard to herWPLA failure to warn claim because strict liability governs such claims. In this instance, we agree. Our case law onthis issue is unsettled, and there is

no binding precedent thatrequires adoption ofa negligence standard when inadequate warnings are given. We instead follow the plain language of Restatement § 402A and holdthatthe usual strict liability standard applies to failure to warn claims. Under the WPLA, a manufacturer is liable where the plaintiff's harm

was "proximately causedbythe negligence ofthe manufacturer" as to design or inadequate warning. RCW 7.72.030(1). However, strict liability generally governs product liability claims because ofthe common law foundation ofthe WPLA. Mqcias, 175 Wn.2d at 409-10. A strict liability standard is also used inRestatement § 402A, which this state adopted. One commentto § 402A, whichwe have likewise adopted, provides an exceptionto the application of

19Taylor v. Intuitive Surgical, Inc. No. 92210-1 

### strict liability for "unavoidably unsafe products." RESTATEMENT (SECOND) OF TORTS: SPECIALLIABILITY OF SELLEROFPRODUCTFORPHYSICAL HARM TO USER ORCONSUMER §

### 402A cmt. k. (AM. LAWlNST. 1965). Comment

### k states: Unavoidably unsafeproducts. 

### There are some products which, in the present state ofhuman knowledge, are quite incapable ofbeing made safe for their intended and ordinary use. These are especially common in the field ofdrugs. An outstanding example is the vaccine for the Pasteurtreatment ofrabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itselfinvariably leads to a dreadful death, both the marketing and the use ofthe vaccine are fullyjustified, notwithstanding the unavoidable high degree ofrisk which they involve. Such aproduct, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably 

### dangerous. The same is true ofmany other drugs, vaccines, and the like, many ofwhich for this very reason cannot legally be sold exceptto physicians, orunder the prescription ofa physician. It

### is also true inparticular ofmany new or experimental drugs as to which, because oflack oftime and opportunity for sufficient medical experience, there can be no assurance ofsafety, orperhaps even ofpurity ofingredients, but such experience as there isjustifies the marketing and use ofthe drug notwithstanding a medically recognizable risk. The seller ofsuch 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 aproduct is inherently dangerous by nature but is still desirable because ofits public benefit, it is an "unavoidably unsafe product" under

20Taylor v. Intuitive Surgical, Inc. No. 92210-1

comment k. Commentk exempts suchproducts from strict liabilityunder § 402A. But comment k specifies that the exception is not available to a manufacturer who fails to adequately warn. Commentk states that "[t]he seller ofsuch products, again with the qualification that they areproperlyprepared andmarketed, and properwarning is given, where the situation calls for it, is not to be held to strict liability." 

### !d. (emphasis added). Thus, by its express terms, properpreparation, marketing, and warnings are prerequisites to a manufacturer being able to qualify for this exceptionto strict liability. It should be noted that although properwarnings are a prerequisite to application ofthe exception, commentk does not governthe adequacy ofthose warnings. However, one thing is clear: comment k is an exception to§ 402A strict liability. Itthus applies only afterthe trier offact determines the prerequisites have been met. Commentk exempts a manufacturer from § 402A's strict liability standard only ifproperwarnings accompanied the product, and we must measure the adequacy ofthose warnings under §402A before applying the exception. To apply the standard ofthe exception before its prerequisites have been met would allow the exceptionto swallowthe rule. Intuitive asserts that negligence, not strict liability, governs duty to warn claims, arguing that "Washington and federal courts have had little difficulty in

21Taylor 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 courthas been divided on this issue, there is no binding precedentthatrequires us to hold that
a negligence standard applies when determining whether commentk applies to failure to warn claims. We instead follow the language ofthe comment itself and hold that the usual strict liability standard applies here. In Terhune, 90 Wn.2d at 12-13, we applied the commentk exceptionto
an intrauterine contraceptive device. However, in that case the evidence was undisputed that the defendant warned the plaintiffsphysician ofthe danger of perforation ofthe uterus upon insertion ofthe device. The courtrejected an argument thatthe defendant owed a duty to warn the plaintiffpatient directly. While the court acknowledged that comment k "does notpurportto 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

### itwarns the physician ofthe 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 inRogers held that the comment k

22Taylor v. Intuitive Surgical, Inc. No. 92210-1 exception did apply. However, even thoughRogers did not involve an inadequate warning claim, in dicta the courtposed 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 mettheir dutyto warnunder commentk. The argument would be that if defendants did not qualify for the comment 

### k exception, then the overall rule-strictliability-would apply. 

### Id. at 207. The court then expressed agreement with the reasoning ofa California case applying a negligence standard. Id. (citingBrown v. Superior Court, 44 Cal.3d 1049, 1059, 751 P.2d470 (1988)). This passage was unnecessary to resolve the certified question at issue, and has neverbeen appliedby a majority ofthis court. In Young v. Key Pharm., Inc., 130 Wn.2d 160, 167-69, 922 P.2d 59 (1996), a four-justice lead opinionrelied onRogers, requiring a negligence standard for failure to warn claims withrespect to unavoidablyunsafe products. However, the four-justice "dissent" concluded thatRogers was notbinding authority onthe standard for failure to warn claims, explaining, "Rogers wrongly applied comment k and Washington law. Exemption from strict liabilityunder commentk is expressly limited to products accompaniedbyadequate warnings. Stated another wayadequate warnings are a predicate to application ofcommentkbythe express terms ofthe comment." Id. at 184 (Madsen, J., dissenting).

23Taylor v. Intuitive Surgical, Inc. No. 92210-1 Since Young, this court addressed commentk another time, but again not in the context ofan inadequate warnings claim. InRuiz-Guzman v. Amvac Chern. Corp., 141 Wn.2d493, 496, 7 P.3d 795 (2000), the sole question pertaining to comment k was whether a pesticide could qualify as an "unavoidably unsafe product" underRestatement § 402A. A failure to warn claim was notraised. 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 orpolicy ofthe WPLA." Id. at 506. Thus, the issue remains unresolved. Because no binding precedent in Washington requires adoption ofa negligence standard here, we follow the language ofthe Restatement itselfand hold that the comment k exception is not available to a manufacturer who fails to adequately warn. Commentk provides that a product is "unavoidably unsafe" onlywhen it is otherwise properly prepared and accompanied by adequate warnings; thus, the exception applies only afterthe trier offact determines that the prerequisites have beenmet. The adequacy ofa manufacturer's warnings are to be measuredunder Washington's strictliability test. Maintaining strict liability for these claims is essential to the purpose of comment, which is to safeguard the public to the greatest extentpossible

24Taylor v. Intuitive Surgical, Inc. No. 92210-1 without discouraging the development and marketing ofunavoidablyunsafe products. Wereverse the trial court's application ofnegligence inthis case. 

### 3. The Trial CourtDidNotErr in Prohibiting Taylor'sRebuttal Evidence Taylor also argues that the trial court erredby excluding one exhibit that Taylorproposed to rebut one witness' testimony. We find that the trial court
was within its discretion to exclude Taylor'sproposedrebuttal evidence in response to an lSI witness' assertion that the robotics program at Harrison Medical Center was successful overall. The trialjudge correctlyrecognized that the proffered evidence was complicated and might have confused thejury. 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 ofthe absence of subsequent accidents using the da Vinci System at HarrisonMedical Center. At trial, lSIput forth testimony from Sean O'Connor, the lSIrepresentative who worked with Harrison Medical Center, who testified about Harrison's robotics program. When Taylor cross-examined O'Connor, Taylor asked O'Connor whetherhehad doubts about the success oftherobotics program. When O'Connor said no, Taylor asked why. O'Connorresponded that "outside ofthis incidentwe're talking about, it[']sbeen a very successfulprogram."

25Taylor v. Intuitive Surgical, Inc. No. 92210-1
6 VRP (Apr. 22, 2013) at 855. A few days later, Taylor offered exhibit 304, a record of233 surgeries at Harrison Medical Center, to rebut the overall success ofthe program. The document listed all robotic procedures and notations about complications. Taylor argued that O'Connor's testimony opened the door to that list. Thetrial court excludedthe 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 shouldpresentthat 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 ofAppeals affirmed. Taylor, slip op. (unpublished portion) at 16-18. Ingeneral, when one party opens the door to a topic, the otherparty may also introduce evidence in orderto establishthe truth for thejury. State v. Gefeller, 76 Wn.2d 449, 455, 458 P.2d 17 (1969). However, all evidence must be relevant. ER402. Even relevant evidence is limited where its probative value is substantially outweighed by the danger ofunfair prejudice, confusion ofthe issues, or misleading thejury. ER403. We review evidentiary challenges for an abuse ofdiscretion. 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 orreasons. 

### !d.

26Taylor v. Intuitive Surgical, Inc. No. 92210-1 Here, excluding exhibit 304 was not an abuse ofdiscretion 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-notlSI. Second, exhibit 304likelywould have confused thejury because it was not offered contemporaneously with O'Connor's testimony or with an expert who could explainthe significance ofthe notations regarding the complications. Thejurywould notknow whether the complications were minor or serious, or whether the various procedures were comparable to prostatectomies. Third, thejudge issued a limiting instruction. As the Court of Appeals observed, ifadmitting 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 CourtDidNotErr by GivingJury Instructions on Superseding Cause orFailure To Mitigate Taylorraises two additional alleged instructional errors. Taylor claims that the trial court erred by instructing thejury onDr. Bildsten's negligence as
a superseding cause andTaylor's own failure to mitigate. Since thejury did notreach these issues because it found in favor ofthe defendant and the Court ofAppeals affirmed, the Court ofAppeals declined to reach these issues.

27Taylor 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 onthese 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 ofthe case, trial courts are required to instruct thejury on the theory. 

### Id. We review a trial court's decision to give ajuryinstruction "denovo ifbasedupon a matter oflaw, or for abuse ofdiscretion ifbased upon a matter offact." 

### 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 ofdiscretion. 

### State v. Walker, 136 Wn.2d 767, 771-72, 966 P.2d 883 (1998). To determine whether to give an instruction, the trialjudge "mustmerely decide whether the record contains the kind offacts to whichthe doctrine applies." 

### Kappelman, 167 Wn.2d at 6.



### a. Superseding Cause The trial court instructed thejury onDr. 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

28Taylor v. Intuitive Surgical, Inc. No. 92210-1 general, we have agreed that the superseding cause theory applies to product liability actions. Campbell v. ITEImperial 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 ofover 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 thejury on superseding cause. b. Failure To Mitigate The trial court instructed thejury that it could consider Taylor's own alleged failure to mitigate. Taylor objectedto the instruction, arguing that giving the instruction was inappropriate because the verdict form allowed the juryto deduct damages twice. Washington law states that the plaintiff's failure to mitigate can be consideredunder the comparative fault statute. RCW 4.22.005. The statute states that the conduct ofbothparties is considered when determining damages. RCW4.22.015. We have held that a "plaintiff's

29Taylor v. Intuitive Surgical, Inc. No. 92210-1 negligence directly reduces plaintiffs recovery bythe percentage ofnegligence involved." ESCA Corp. v. KPMGPeatMarwick, 135 Wn.2d 820, 830, 959 P.2d 651 (1998). Here, it was appropriate for the trial courtto include the instruction to consider any potential mitigation ofotherparties, as facts were adduced at trial aboutthe fault ofDr. Bildsten and Taylor. The verdict form allowed a place for thejuryto fill in percentages offault 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 pursuantto the WPLA, manufacturers have a dutyto warn hospitals about the dangers oftheirproducts. The manufacturer's warnings to Dr. Bildsten did not excuse its duty to warn HarrisonMedical Center. As such,

we find thatthe trial court erred in failing to instructthejury onthis duty. We vacate thejury's defense verdict and remand for a newtrial. Further, we hold that the commentk exception inRestatement § 402A is not available to a manufacturerwho fails to adequately warn andreverse the trial court's application ofnegligence in this case.

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



### WE CONCUR:

# (~/Q 

# /

31Taylor, 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 ofthe 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 ofthe dangers ofthe "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 thejury 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 ofthe dangers oftheir products because the WPLA states that aproduct is not reasonably safe ifadequate warnings are not provided withthe product. See majority at 11 (citing RCW 7.72.030(1)(b)). Thus, because Harrison was the purchaser ofthe da Vinci System, lSI had a duty to provide warnings to Harrison. Although I concur with the majority's conclusion based on the textNo. 92210-1 Madsen, J., dissenting
ofthe 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 thatthe manufacturer owes the purchaser. The manufacturer must provide productwarnings with the product thatthe purchaserpurchases. See majority at 11. Here, lSI would owe this duty to Harrison. So iflSI breached this duty, Harrison wouldpresumablyhave a claim against lSI. ButTaylor 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 productto Harrison, Harrison credentialed the doctor, and the doctor ultimately operated on Taylor's husband using the product. Although different duties exist in that chain ofevents, none supports this claim. First, a duty to Taylor from lSI does notpass through the doctor. As this court has said, it is a well-established rule that "the duty ofthe manufacturerto warn of dangers involved in use ofaproduct is satisfied ifhe 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.

2No. 92210-1 Madsen, J., dissenting Second, a duty to Taylor from lSI does notpass 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. Butby 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 ofHarrison 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 ofa duty that was owed to another. She has no claim against lSI for a breach ofits duty to Harrison. Because Harrison is not
aparty to this case and thus cannot assert a claim against lSI, the trial court did not err by not instructing thejury as to the duty that lSI owed Harrison. Even ifthe trial court erroneously believed that no such duty existed, remanding this case would not suddenly give Taylor a cause ofaction to invoke a duty owed to another. Accordingly, I respectfully dissent.

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

4