American Journal of Law & Medicine

Washington Supreme Court Holds That Medical Device Manufacturers Have a Duty to Warn Hospitals-Taylor V. Intuitive Surgical, Inc

On February 9, 2017, in an opinion written by Justice Susan J. Owens, the Washington Supreme Court vacated a defense jury verdict finding that Intuitive Surgical, Inc. (Intuitive Surgical), was not liable under the Washington Tort Reform and Product Liability Act (WPLA) (2) for injuries resulting from complications during a robotically-assisted radical prostatectomy. (3) In a six-three decision, the Washington Supreme Court held that under Washington law, medical device manufacturers have a duty to warn hospitals of their products' dangers. (4) The Court stated that the text of the WPLA creates a new duty that entitles the purchaser of a medical device to provide product warnings about the product it purchases. (5) Furthermore, the Court held that the learned intermediary doctrine does not remove a manufacturer's duty under the WPLA to warn hospitals about medical equipment purchased by that hospital. (6)

Intuitive Surgical designs, manufactures, and markets the da Vinci[R] Surgical System (the da Vinci System), an advanced surgical system that allows for robotically-assisted, minimally invasive surgery. (7) The da Vinci System facilitates minimally invasive robotic surgery by translating the surgeon's natural hand movements into corresponding micro-movements of instruments positioned inside the patient through small incisions, or ports. (8) The United States Food and Drug Administration (FDA) cleared the da Vinci System for marketing pursuant to the 510(k) process. (9) In particular, Intuitive Surgical obtained clearance from the FDA to market the da Vinci System in the United States for use in general laparoscopic procedures (10) and prostatectomy procedures. (11)

In 2008, Fred Taylor underwent a radical da Vinci prostatectomy by Doctors Scott Bildsten and John C. Hedges at Harrison Medical Center. (12) Four years after the da Vinci prostatectomy, Mr. Taylor died. (13) Mr. Taylor's widow, Josette Taylor, filed a product liability, negligence, contract, wrongful death, and survival action against Intuitive Surgical in Washington Superior Court under the WPLA. (14) According to the complaint, Intuitive sales representatives misled and improperly pressured Dr. Bildsten to perform his first unsupervised robotic surgery on Mr. Taylor after only two supervised or "proctored" cases. (15) Mrs. Taylor claimed Mr. Taylor suffered complications during and as a result of surgery, including kidney and muscle damage and death. (16) However, at the time of the da Vinci prostatectomy, Mr. Taylor was considered "severely obese" and had a body mass index (BMI) of of thirty-nine, despite Intuitive Surgical's recommendation that surgeons operate on patients with a BMI of less than thirty. …

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