Taylor v. Intuitive Surgical, Inc.

• Citation: 188 Wash.App. 776,355 P.3d 309
• Decision Date: 07 July 2015
• Docket Number: No. 45052–6–II.,45052–6–II.
• Court: Court of Appeals 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, Appellant, v. INTUITIVE SURGICAL, INC., a foreign corporation doing business in Washington, Respondent.

188 Wash.App. 776

355 P.3d 309

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, Appellant

v.INTUITIVE SURGICAL, INC., a foreign corporation doing business in Washington, Respondent.

No. 45052–6–II.

Court of Appeals of Washington, Division 2.

July 7, 2015.

William Siemon Cummings, Friedman Rubin, Bremerton, WA, Carol Nofziger Johnston, Jane Morrow, Otorowski Johnston Morrow & Golden PLLC, Kenneth Wendell Masters, Masters Law Group PLLC, Bainbridge Island, WA, Richard Friedman, Friedman Rubin, Bremerton, WA, Peter J. Mullenix, Friedman Rubin, Seattle, WA, for Appellant.

Jeffrey Royal Johnson, Gregory Paul Thatcher, Scheer & Zehnder LLP, Philip Albert Talmadge, Talmadge/Fitzpatrick, Seattle, WA, for Respondent.

Barbara Allan Shickich, Brett S. Durbin, Riddell Williams P.S., Seattle, WA, Amicus Curiae on behalf of Washington State Hospital Association.

PUBLISHED IN PART OPINION

MELNICK, J.

¶ 1 Josette Taylor, individually and in her capacity as the personal representative of the estate of her husband Fred E. Taylor,¹ appeals from a jury verdict finding no liability by Intuitive Surgical, Inc. (ISI) under the Washington Tort Reform and Product Liability Act (WPLA),² for Taylor's injuries resulting from complications during a robotically assisted prostatectomy

.³ Taylor argues that the trial court erred by not instructing the jury that (1) ISI, manufacturer of the system used to perform the surgery, owed a duty to warn the hospital in addition to the surgeon, and (2) strict liability governed the duty to warn. In the published portion of this opinion, we hold that under the learned intermediary doctrine, ISI only had a duty to warn the surgeon and not the hospital. We further hold that a negligence standard governs the duty to warn a learned intermediary about a medical product.

¶ 2 Taylor further argues that the trial court abused its discretion by refusing to allow Taylor to introduce evidence of other incidents concerning ISI's product. In the unpublished portion of this opinion, we hold that the trial court did not abuse its discretion by excluding Taylor's evidence of other incidents with ISI's product. Accordingly, we affirm the trial court.⁴

FACTS

I. Background

¶ 3 ISI designs, manufactures, and markets the da Vinci System. The da Vinci System facilitates minimally invasive robotic surgery by allowing a surgeon to remotely operate very small instruments that are inserted inside the patient's body through incisions much smaller than those used in traditional (open-patient) surgery. The use of small incisions often results in shorter recovery times, fewer complications, and reduced hospital costs. A robotic surgery may not, however, remove as much cancer

as an equivalent open procedure. Despite these shortcomings, the da Vinci System is now used in approximately 84 percent of prostatectomy surgeries in the United States.

¶ 4 The da Vinci System is a fairly new technology, having been used for the first time on humans in 1997. In 2001, the Food and Drug Administration (FDA) cleared ISI to market the da Vinci System for prostatectomy

surgery, finding that the da Vinci System was “substantially equivalent” to devices that the FDA had cleared in the past.⁵ Clerk's Papers (CP) at 344; see Federal Food, Drug, and Cosmetic Act, § 510(k), 21 U.S.C. § 360(k). The da Vinci System is restricted “to sale by or on the order of a physician.” CP at 364.

¶ 5 The da Vinci System is a highly complex medical device. While the learning curve varies from surgeon to surgeon, ISI estimates that between 20 and 30 da Vinci System surgeries are needed before a surgeon will be comfortable with the system. Although ISI's learning curve estimation is consistent with some scholarly research, other researchers believe that “[s]urgeon comfort and confidence” is not attained until a surgeon has performed between 150 and 250 robotic procedures. Report of Proceedings (RP) (May 1, 2013) at 1948.

¶ 6 As part of their training, ISI requires surgeons who are just beginning with the da Vinci System to undergo either two proctored cases or an amount set by hospital protocol. Following that, ISI requires surgeons to choose simple cases for their first four to six unproctored procedures and to “slowly progress in case complexity.” Supp. CP at 6029. During their first surgeries with the da Vinci System, surgeons performing prostatectomies

are advised to choose patients with a body mass index (BMI) of less than 30 and no prior history of lower abdominal surgery. ISI specifically warns surgeons not to use the da Vinci System if a patient exhibits “morbid obesity.” CP at 159. Furthermore, ISI recommends that da Vinci System operators place their patients in a steep Trendelenburg position, which means an incline of greater than 20 degrees. This position is recommended to make it easier for the surgeon to see what he or she is doing.

¶ 7 Before a doctor may perform a procedure at a hospital or medical institution, he or she must be credentialed by the institution. Each institution determines its own credentialing process. ISI recommends to hospitals that surgeons credentialed to use the da Vinci System “meet basic and advanced laparoscopic requirements.”⁶ CP at 5798.

II. Taylor's Surgery

¶ 8 Dr. Scott Bildsten, who performed Taylor's surgery, took an early interest in the da Vinci System. At the time of Taylor's surgery, Dr. Bildsten had extensive experience in traditional open surgery and had performed between 80 and 100 open prostatectomies

. He also had experience in performing hand-assisted laparoscopic procedures, meaning he operated with one hand outside of the patient's body.

¶ 9 Dr. Bildsten received training from ISI and Harrison Medical Center credentialed him in operating the da Vinci System. As part of his training, Dr. Bildsten observed more than ten surgeries involving the da Vinci System, and he performed two proctored surgeries using the da Vinci System. Although the proctored surgeries were “fairly long,” Dr. Bildsten thought he had done “really well” and felt encouraged to continue using the da Vinci System. RP (Apr. 23, 2013) at 1067, 1071. Dr. Bildsten denied that ISI ever pressured him into performing robotic surgery.

¶ 10 In 2008, Dr. Bildsten treated Taylor for prostate cancer

. They discussed various courses of treatment, but Taylor insisted on a prostatectomy. They also discussed the possibility of a robotic procedure, and Dr. Bildsten advised Taylor that he was “just starting with the robotic technique.” RP (Apr. 23, 2013) at 1067. Taylor agreed to start with a robotic surgery and to convert to an open procedure in the event of “any potential unsafe situations.” RP (Apr. 23, 2013) at 1067.

¶ 11 By Dr. Bildsten's own admission, because of Taylor's morbid obesity

,⁷ he was not an optimal candidate for a prostatectomy. Dr. Bildsten understood that he should only operate on thin patients while he was still new to the da Vinci System. Taylor had received numerous surgeries in the past, including three abdominal surgeries. He also suffered from “uncontrolled” diabetes, coronary artery disease, hypertension, and high cholesterol. RP (Apr. 24, 2013) at 1346. Doctors prescribed cholesterol medications for Taylor, but he did not consistently take them.

¶ 12 Nevertheless, in his first non-proctored surgery with the Da Vinci system, Dr. Bildsten operated on Taylor. Dr. Bildsten could not put Taylor in the steep Trendelenburg position because of Taylor's “abdominal girth.” CP at 253. As a result, Dr. Bildsten had no choice but to flatten out Taylor to a slighter incline, which made it difficult to see what he was doing “due to the intestinal contents continually getting into the visual field.” CP at 253. After “several hours of trying to get better visualization,” Dr. Bildsten gave up on the da Vinci System and converted the procedure to an open prostatectomy

. CP at 253. At some point during the open procedure, Dr. Bildsten tore Taylor's rectal wall with his finger. Fecal matter escaped Taylor's rectum and caused a blood infection.

¶ 13 Taylor remained in the operating room for approximately 15 hours. He suffered various complications from being under anesthesia

for too long. He experienced a massive breakdown of muscle and kidney failure because he was not moving and his blood was not circulating properly. He also experienced brain swelling because his head was tilted down for an extended time during surgery.

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

to help him breathe for much of this time. Taylor had nerve and muscle damage, which may have been caused by his protracted stay in the intensive care unit. He also suffered a stroke

during his stay in the intensive care unit.

III. Aftermath

¶ 15 Taylor's quality of life diminished following his prostatectomy

. He suffered weakness in his shoulders, back, hip, and left arm; an atrophied right thigh; incontinence; and cognitive deficits including poor memory, depression, and anxiety. He needed a cane to walk most of the time. Losing his independence caused Taylor a great deal of frustration.

¶ 16 Taylor died in 2012, four years after his prostatectomy

. The cause of death was preexisting “hypertensive cardiovascular disease.” RP (May 6, 2013) at 2200–01. The parties dispute whether the prostatectomy hastened Taylor's death.

PROCEDURAL HISTORY

¶ 17 Based on various legal theories, Taylor sued Dr. Bildsten, Dr. Bildsten's partner and medical practice, Harrison Medical Center, and ISI. In an amended complaint, Taylor dropped Harrison Medical Center as a defendant. Taylor also settled with the doctors and their medical practice, leaving ISI as the only defendant for trial. The trial court granted ISI's summary judgment motion on all of Taylor's claims, except for the WPLA claim. Taylor does not assign error on appeal to this order granting summary...