Taylor v. Intuitive Surgical, Inc.

• Citation: 187 Wash.2d 743,389 P.3d 517
• Decision Date: 09 February 2017
• Docket Number: No. 92210-1,92210-1
• Court: United States State Supreme Court of Washington
• Parties: 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.

187 Wash.2d 743

389 P.3d 517

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.

No. 92210-1

Supreme Court of Washington.

Argued June 7, 2016

Filed Feb. 9, 2017

Kenneth Wendell Masters, Shelby R. Frost Lemmel, Masters Law Group PLLC, 241 Madison Ave. N., Bainbridge Island, WA, 98110-1811, for Petitioner.

Jeffrey Royal Johnson, Scheer Law Group LLP, 701 Pike St., Ste. 2200, Seattle, WA, 98101-2358, Philip Albert Talmadge, Sidney Charlotte Tribe, Talmadge/Fitzpatrick/Tribe, 2775 Harbor Ave. S.W., Third Floor, Ste. C, Seattle, WA, 98126-2138, Allen J. Ruby, Skadden Arps Slate Meagher & Flom, 525 University Avenue, Suite 1100, Palo Alto, CA, 94301, for Respondent.

Christopher W. Tompkins, Betts Patterson & Mines PS, 701 Pike St., Ste. 1400, Seattle, WA, 98101-3927, Hugh F. Young, Product Liability Advisory Council, Inc., 1850 Centennial Park Dr., # 510, Reston, VA, 20191, James M. Beck, Reed Smith LLP, 1717 Arch Street, Suite 3100, Three Logan Square, Philadelphia, PA, 19103, as Amicus Curiae on behalf of Product Liability Advisory Council, Inc.

Valerie Davis Mcomie, Attorney at Law, 4549 N.W. Aspen St., Camas, WA, 98607-8302, Bryan Patrick Harnetiaux, Attorney at Law, 517 E. 17th Ave., Spokane, WA, 99203-2210, Daniel Edward Huntington, Richter-Wimberley PS, 422 W. Riverside Ave., Ste. 1300, Spokane, WA, 99201-0305, as Amicus

Curiae on behalf of Washington State Association for Justice Foundation.

David Bartley Eppenauer, Shook, Hardy & Bacon LLP, 701 5th Ave., Ste. 6800, Seattle, WA, 98104-7066, Victor E. Schwartz, Phil Goldberg, Shook, Hardy, & Bacon, 1155 F Street N.W., Suite 200, Washington, DC, 20004, as Amicus Curiae on behalf of Medical Device Manufacturers Association.

David Bartley Eppenauer, Shook, Hardy & Bacon LLP, 701 5th Ave., Ste. 6800, Seattle, WA, 98104-7066, Victor E. Schwartz, Phil Goldberg, Shook, Hardy, & Bacon, 1155 F Street N.W., Suite 200, Washington, DC, 20004, as Amicus Curiae on behalf of National Association of Manufacturers.

Barbara Allan Shickich, Riddell Williams PS, 1001 4th Ave., Ste. 4500, Seattle, WA, 98154-1065, Brett S. Durbin, Stoel Rives LLP, 600 University St., Ste. 3600, Seattle, WA, 98101-4109, Sarah Elizabeth Joye, Riddell Williams P.S., 1001 4th Ave., Ste. 4500, Seattle, WA, 98154-1065, as Amicus Curiae on behalf of Washington State Hospital Association.

OWENS, J.

¶1 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

¶2 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.

¶3 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.

¶4 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.

¶5 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.

¶6 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.

¶7 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.

¶8 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, Taylor¹ 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.

¶9 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.

¶10 The jury returned a verdict in favor of ISI. It found specifically that ISI...