In Washington, manufacturers of medical devices now have a duty to warn hospitals that purchase their devices. Additionally, product manufacturers of “unavoidably unsafe products” face strict liability for failure to warn claims. Taylor v. Intuitive Surgical, Inc., No. 92210-1, 2014 Wash. LEXIS 200 (Feb. 9, 2017). The Washington Supreme Court ruling may impose a new duty on any product manufacturer that sells its product through intermediaries, not only medical device manufacturers.

Intuitive Surgical manufactures and sells the da Vinci System, a robotic device used by credentialed surgeons for laparoscopic surgeries. The da Vinci System was sold to a Washington hospital that credentialed certain physicians to perform surgeries using the device. Intuitive Surgical provided doctors with a user’s manual that contained various warnings related to the use of the device.

In this case, the doctor performing the surgery allegedly failed to follow all of the warnings when he elected to use the da Vinci System. The patient developed complications that reduced his quality of life and ostensibly hastened his death. The patient’s wife sued the doctor and his medical practice, the hospital, and Intuitive Surgical. Before trial, the plaintiff settled with all parties except Intuitive Surgical.

The jury returned a defense verdict for Intuitive Surgical, concluding that it provided appropriate warnings to the doctor. On appeal, the plaintiff claimed the trial court erred when it declined to instruct the jury that Intuitive Surgical had a duty to warn the hospital and when it applied a negligence standard instead of a strict liability standard to the failure to warn claim.

The Washington Supreme Court held that the Washington Product Liability Act “imposes a duty on manufacturers of medical products to warn hospitals of the products’ dangers when they purchase them” and that this duty “is not excused when a manufacturer warns doctors who use the devices because hospitals need to know the dangers of their own products.” Id. at *11. The court concluded that although the duty is not explicitly stated in the text of the statute, the statute states that a “product is not reasonably safe because adequate warnings or instructions were not provided with the product.” Id. at *13 (quoting RCW 7.72.030(b)). Therefore, according to the text of the statute, the purchaser, here the hospital, is owed product warnings with the product it purchases. The court found this conclusion to be supported by the requirement that hospitals adopt credentialing requirements for its medical staff, and in particular that the hospital in this case had a credentialing process related to the use of the da Vinci System. Thus, the court stated, “it follows that hospitals need product warnings to design a credentialing process that will keep patients as safe as possible.” Id. at *14.[1]

The court rejected the learned intermediary doctrine, whereby manufacturers of medical products can satisfy their duty to warn patients of the risks of their products by providing those warnings to the doctors prescribing the products. In such a case, the manufacturers’ duty to warn is transferred to the doctor, who is “in a better position to communicate them to the patient.” Id. at *17. Unlike in the doctor-patient relationship, the hospital is the gatekeeper between the physician and the da Vinci System because the hospital credentials surgeons to use it. According to the court, hospitals have an independent duty to ensure that a device is used safely. Hospitals cannot meet that duty if they are not informed of the risks of its use.

Additionally, the court interpreted comment k to the Restatement (Second) of Torts § 402A, as applied to “unavoidably unsafe products.” Comment k applies a negligence standard to products liability claims associated with unavoidably unsafe products — products that are incapable of being made safe but that are not deemed unreasonably dangerous because of the apparent usefulness of the product. The court held that comment k applies only to products that are “properly prepared and marketed and proper warning is given.” The court thus held that “[c]omment k exempts a manufacturer from [the Restatement’s] § 402A’s strict liability standard only if proper warnings accompanied the product, and we must measure the adequacy of those warnings under § 402A before applying the exception.” Id. at *25 (emphasis in original). The court then applied § 402A’s strict liability standard to Intuitive Surgical’s duty to warn.

For product manufacturers, this ruling creates a new strict liability standard for failure to warn claims, and potentially expands the parties in a distribution chain to whom a duty to warn is owed. For insurers, this ruling may increase the potential exposure to insured product manufacturers by expanding the parties to whom a duty is owed and creating a strict liability standard.