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Taylor v. Intuitive Surgical, Inc.

Supreme Court of Washington, En Banc

February 9, 2017

JOSETTE TAYLOR, as Personal Representative of the Estate of FRED E. TAYLOR, deceased; and on behalf of the Estate of FRED E. TAYLOR; and JOSETTE TAYLOR, individually, Petitioner,
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 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. (ISI) is the manufacturer of a robotic surgical device called the "da Vinci System, " which surgeons use to perform laparoscopic surgeries. ISI manufactures and markets the da Vinci System robotic device to medical centers, including Harrison Medical Center, which purchased the device. The device is used for robotic laparoscopic surgeries, which are minimally invasive because surgeons remotely operate on the person by inserting the robotic instruments into the patient through small incisions. Since laparoscopic procedures use small incisions through the skin, the recovery times are much shorter and the surgeries result in fewer complications than alternative methods. Presently, the da Vinci System is used in about 84 percent of prostatectomies in the United States.

         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, ISI requires that surgeons perform two proctored surgeries, but hospitals enforce their own requirements for credentialing surgeons to use the da Vinci System. Harrison Medical Center provided credentials after those two proctored procedures. Other hospitals in Washington provided credentials after three or four proctored surgeries. See 6 VRP (Apr. 22, 2013) at 774-75 (Tacoma General Hospital requiring three); 14 VRP (May 7, 2013) at 2408 (Swedish Medical Center requiring four). ISI recommends that surgeons choose "simple cases" for initial unproctored procedures. Clerk's Papers (CP) at 6029. ISI provided a user's manual to doctors, containing various warnings related to the device. Three warnings are particularly relevant to this case. First, as part of its training, ISI advised surgeons not to perform prostatectomies on obese persons. ISI provided body mass index (BMI) guidelines stating patients should have a BMI of less than 30. Second, ISI advised not to perform prostate procedures on persons who previously underwent lower abdominal surgeries. Third, ISI warned that it was unsafe for the patient not to be in a steep Trendelenburg position (tilted with head downward) during the procedure.

         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 had a BMI of 39 (contrary to ISI's advice to choose a patient with a BMI of less than 30), Dr. Bildsten testified that he considered Taylor to be "severely obese." 7 VRP (Apr. 23, 2013) at 1140. Furthermore, Taylor had three prior lower abdominal surgeries (which went against ISI's advice to avoid patients with prior lower abdominal surgeries). During the surgery, Dr. Bildsten did not position Taylor in the steep Trendelenburg position due to his weight (in spite of ISI's advice to conduct the procedure in that position). Although Dr. Bildsten knew that Taylor "was not an optimal candidate, " he performed the prostatectomy as his first unproctored procedure using the robotic system. Id. at 1063.

         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.

         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 ISI. 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. ISI was the only remaining defendant. Taylor proceeded against ISI for claims of product defect, breach of warranty, breach of contract, violation of Washington's Consumer Protection Act (ch. 19.86 RCW), negligence, and product liability under the WPLA. The trial court granted summary judgment in favor of ISI on all claims, except for Taylor's failure to warn claim under the WPLA.

         At trial, ISI presented expert testimony that described the ISI training process. Dr. Joel Lilly, a urologist with significant robotic surgical experience, discussed the ISI training course. ISI trained surgeons on "how to select your best candidates for starting your experience, " such as choosing "thin patients" and those with no prior abdominal surgery. 14 VRP (May 7, 2013) at 2405. Dr. Lilly told the jury that in his opinion, Dr. Bildsten was negligent in performing Taylor's surgery.

         The jury returned a verdict in favor of ISI. It found specifically that ISI was not negligent in providing warnings or instruction to Dr. Bildsten. Taylor appealed, raising several assignments of error. First, Taylor claimed that the trial court erred by declining to instruct the jury that ISI had a duty to warn Harrison Medical Center. The Court of Appeals found by a 2-1 decision that the trial court did not err because ISI fulfilled its duty to warn by warning Dr. Bildsten. Taylor v. Intuitive Surgical, Inc., 188 Wn.App. 776, 792, 797-98, 355 P.3d 309 (2015) (published in part). Second, Taylor claimed that the trial court erred by applying a negligence standard instead of a strict liability standard. The Court of Appeals unanimously found that the trial court properly applied a negligence standard to the inadequate warning claim. Id., at 794. Third, Taylor claimed that the trial court erred by excluding Taylor's evidence to rebut ISI's testimony that Harrison Medical Center's robotic surgery program was successful overall. In the unpublished portion of its opinion, the Court of Appeals unanimously agreed that the trial court did not abuse its discretion by excluding this evidence as confusing and prejudicial. Taylor, slip op. (unpublished portion) at 16-18, http://www.courts.wa.gov/Opinions. Finally, Taylor challenged jury instructions on superseding cause and failure to mitigate. Since the jury did not reach these issues and the Court of Appeals affirmed the trial court, it did not reach these additional assignments of error. Taylor, 188 Wn.App. at 780 n.4. Here, Taylor seeks review of these assignments of error. We granted review. Taylor v. Intuitive Surgical, Inc., 184 Wn.2d 1033, 379 P.3d 957 (2016).

         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 ISI.

         ISSUES

         1. Did ISI 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?

         ANALYSIS

         Taylor claims the trial court erred in four ways. First, Taylor claims the trial court erred by not instructing the jury on ISI's duty to warn Harrison Medical Center as the purchasing hospital. Second, Taylor claims the trial court erred in its application of the negligence standard rather than strict liability. Third, Taylor claims the trial court erred by excluding Taylor's rebuttal evidence to ISI's testimony that Harrison Medical Center's robotics surgery program was successful overall. Fourth, Taylor claims the trial court erred by instructing the jury on superseding cause and failure to mitigate. As explained below, we find that the trial court erred by not instructing the jury on ISI's duty to warn the purchasing hospital. Accordingly, we vacate the defense verdict and remand for retrial. Although we need not reach Taylor's additional claims, we reach them to provide guidance for the trial court should these issues arise on retrial.

         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 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 of Product 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 ISI 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 of cases prior to the enactment of the WPLA. See LAWS OF 1981, ch. 27; Terhune v. AM. Robins Co., 90 Wn.2d 9, 12, 577 P.2d 975 (1978); see also Ulmer v. Ford Motor Co., 75 Wn.2d 522, 531-32, 452 P.2d 729 (1969) (adopting the Restatement''s liability standard for a manufacturer case). Thus, although the WPLA governs product harm claims, some case law regarding product harm cases comes from Restatement principles.

         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 ...


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