Here are the Monitor we routinely cover the learned intermediary doctrine and its application in failure to warn suits. Just last week, the Court of Appeals of the State of Washington tackled an issue of first impression in Taylor v. Intuitive Surgical, Inc., No. 45052-6-II, 2015 WL 4093346 (Wash. Ct. App. July 7, 2015). There the court addressed whether a manufacturer of a medical device had a duty to provide warnings to not only the physician, but also to the hospital that purchased the equipment. In analyzing the policies behind the learned intermediary doctrine, the Appellate Court found that the manufacturer’s duty ran only to the physician, not the hospital, thereby affirming a jury verdict finding the device manufacturer not liable.
Here, Intuitive Surgical, Inc. (“ISI”) designed, manufactured, and marketed the da Vinci System, which facilitates robotic surgery, allowing a surgeon to remotely operate with small incisions, leading to quicker and easier recoveries. The da Vinci System is “a highly complex medical device” and some researchers have estimated that approximately 150 to 200 robotic procedures are necessary for a surgeon to be completely comfortable with the system. Id. at *1. ISI provided Dr. Bildsten training on the da Vinci System, and Harrison Medical Center, the hospital where he worked, credentialed him in operating the system.
In 2008, Dr. Bildsten treated Appellant Taylor for prostate cancer and performed a robotic surgery utilizing the da Vinci System. As Dr. Bildsten admitted, Appellant was not an ideal candidate for the procedure due to his obesity, past surgeries, as well as other pre-existing health issues. During the surgery, Dr. Bildsten could not place Appellant in the steep position that ISI recommends due to his weight. As a result, Dr. Bildsten had difficulty seeing during the robotic surgery, which eventually led him to give up on the system and instead opt for an open prostatectomy. As a consequence, Appellant was in the operating room for fifteen hours and suffered various health consequences. Appellant passed away four years after his surgery and the parties disputed whether the prostatectomy contributed to his death.
At trial, Taylor’s proposed jury instructions stating that ISI had a duty to warn not only Dr. Bildsten, but also Harrison Medical Center. The trial court rejected those instructions and instead instructed the jury that ISI’s duty to adequately warn ran solely to the doctor. The jury returned a verdict in favor of ISI, and Taylor appealed.
On appeal, Appellant argued that ISI’s duty to warn also ran to Harrison Medical Center as the purchaser of the da Vinci System. Rejecting that argument, the Appellate Court explained that under the learned intermediary doctrine a manufacturer’s duty to warn runs solely to the prescribing physician, who in turn, has a duty to warn the ultimate consumer. The Court further explained that the “learned intermediary doctrine is not concerned with who pays for the product or who retains possession of the product. Rather its rationale is based on the physician’s role as gatekeeper who stands in the place of the manufacturer in relation to the patient to provide warnings about…products accessible only by prescription.” Id. at *6. The Appellate Court found that the doctrine’s policies dictate that “the hospital does not share in the physician’s role as a learned intermediary” which “singles out the physician” who had final control over the use of the da Vinci System. Id. at *7. Although Appellant argued that if the hospital had not purchased the system, he would not have received the robotic surgery, the Court rejected this claim, explaining that like a pharmacist, a “third party that facilitates the distribution of a medical product, yet does not exercise its own individualized medical judgment, is not a learned intermediary.” Id.
This decision, however, came along with a dissent, which argued that the learned intermediary doctrine should not apply to a manufacturer’s failure to warn a hospital that has purchased a medical product. The dissent explained that “[w]hile a physician is a gatekeeper between the manufacturer and the unwarned patient, a physician is not a gatekeeper between the manufacturer and the unwarned hospital because the physician does not use independent judgment to determine which medical products a hospital should receive and what information a hospital needs to know about those products.” Id. at *12. Instead, the dissent claimed that “the hospital exercises independent judgment to determine which medical products it should purchase and receives information about those products directly from the manufacturer.” Id.
This decision emphasizes manufacturers’ ability to satisfy their duty to warn in many cases by providing adequate warnings solely to physicians.