Dangerous Medical Device Manufacturers Owe Legal Duty to Warn Hospital, Washington Supreme Court Holds

On February 9, 2017, the State Supreme Court issued Taylor v. Intuitive Surgical, Inc., ___ Wn.2d ___, 389 P.3d 517 (2017), where the Court held that a manufacturer of a dangerous medical device, as defined by the Washington Product Liability Act (WPLA), owes a legal duty to warn a hospital that purchases the device, and that strict liability standards, and not negligence, will measure whether the warnings to the hospital were adequate.

Taylor v. Intuitive Surgical, Inc.

In 2008, a urological surgeon performed a robotic prostatectomy on a patient at Harrison Medical Center, his first unproctored prostatectomy.[1] The patient weighed 280 lbs., had had three prior lower abdominal surgeries, and the surgeon did not place the patient in the Trendelenburg position. The manufacturer of the robot used in the surgery, Intuitive Surgical Inc. (ISI), had provided a user’s manual to the physician warning against using the robot for prostatectomies in such circumstances. During the surgery, serious complications arose and the patient died four years after the surgery. The patient’s estate filed suit against the surgeon, the hospital and ISI.[2]

The only claim that went to the jury was a failure to warn claim against ISI under the WPLA. The jury returned a verdict for ISI, concluding that ISI was not negligent in providing warnings or instructions to the surgeon. The Court of Appeals affirmed the defense verdict.[3]

The Supreme Court in Taylor reversed and vacated the jury’s defense verdict. It first held that it was error to not instruct the jury that ISI had a duty to warn the hospital regarding the use of the device.[4]The Court concluded that the manufacturer’s duty to warn the purchasers of the product is contained in the plain text of the WPLA. The Taylor Court explicitly tied the manufacturer’s duty to warn to the hospital’s independent duties to patients under the corporate negligence doctrine.[5] It reasoned that because hospitals have an “independent duty” to credential and perform a “due-diligence evaluation” to determine if the surgeon was competent to perform the surgery, hospitals need product warnings to design a credentialing process “that will keep patients as safe as possible.”[6]

The Court further rejected ISI’s reliance on the learned intermediary doctrine[7], concluding that the WPLA imposes a separate and distinct duty for the manufacturer to provide warnings to the purchaser of the product, as opposed to the end user of the product (the patient).[8] The Taylor Court ruled explicitly that the physician is “not a learned intermediary between the manufacturer and the hospital” and the doctrine does not apply to the case or excuse the manufacturer’s duty to warn.[9]

Second, the Taylor Court held that it was error for the trial court to apply the negligence standard instead of strict liability to the failure to warn claim.[10] The Court noted that the case law on the issue was unsettled, but chose to follow the plain language Restatement (Second) Torts § 402A, which imposes strict liability on product sellers and which has been adopted in Washington. The Court rejected the application of “comment k” to the Restatement, which is an exception to strict liability where the product is unavoidably unsafe in its intended and ordinary use.[11] The Taylor Court ruled that the exception is not available to a manufacturer who fails to adequately warn, and can apply only if the trier of fact determines that proper warnings accompanied the product, measured by a strict liability standard.[12]


The central holdings announced in Taylor present a significant change in Washington law, which had never recognized a separate duty to warn the purchaser of the dangers of a medical device in this context, and had never held that a strict liability analysis on the adequacy of warnings was a prerequisite to applying the comment k exception to strict liability. Nor has the Court on previous occasion suggested that a manufacturer owes a duty to warn hospitals under the WPLA, partially because the hospital owes an independent duty to patients under the common law corporate negligence doctrine, including the duty to adequately credential its physicians. In light of the Taylor Court’s ruling, the manufacturer’s duty to the hospital is now intertwined, and partially informed by, the hospital’s independent duties to the patient.

The Taylor Court’s ruling creates myriad legal and practical challenges to both manufacturers and hospitals. For instance, the opinion provides little if any guidance as to how a manufacturer would be able to investigate and possibly question the credentialing process of the hospital to ensure that hospitals and physicians are aware of the risks of using the device. How the duty announced by theTaylor Court is met by the manufacturer is largely an unanswered question.

Indeed, the surgeon in Taylor did not heed the instructions provided by the manufacturer to both the hospital and the physician, and moved forward with the surgery despite the risks and despite being properly credentialed by the hospital. The Court does not answer how the negative outcome of the surgery could have been prevented without an intrusion of the physician-patient relationship, including the informed consent process, by both the hospital and the manufacturer. Its reasoning also gives rise to the potentiality that the manufacturer is held strictly liable because of a physician’s clinical decision, despite providing adequate warnings to the physician, under the presumption that the hospital was in a position to second-guess the physician’s decision if it had independently received warnings from the manufacturer.

The Taylor Court’s ruling could also have far-reaching implications that ultimately harm the public interest. It could disincentivize manufacturers from developing new medical devices that will benefit patients, but that are unavoidably unsafe, because they will effectively act as guarantors of the devices’ usage. This could particularly become an issue if the manufacturers are unable to develop a method of meeting their legal duty without intruding on legal duties owed by separate entities and persons as a means of limiting their possible liabilities.

If you have questions about this client alert or related topics, please feel free to contact either of the attorneys below:

Bill Leedom (wleedom@bbllaw.com)

David Norman (dnorman@bbllaw.com)

[1] 389 P.3d at 521.
[2] Id.
[3] See Taylor v. Intuitive Surgical Inc.,188 Wn. App. 776, 355 P.3d 309 (2015).
[4] 389 P.3d at 522-24.
[5] 389 P.3d at 524.
[6] Id.
[7] The learned intermediary doctrine refers to a rule where if the manufacturer, typically of prescription drugs or medical products, gives adequate warnings to the prescribing health care provider, the manufacturer usually has no duty to warn the end user of the product. See, e.g., Washington State Physicians Ins. Exch. v. Fisons Corp., 122 Wn.2d 299, 858 P. 2d 1054 (1993) (prescription drug); McKee v. Am. Home Prod.. Corp., 113 Wn.2d 701, 720, 782 P.2d 1045 (1989) (prescription drug); Terhune v. A.H. Robins Co., 90 Wn.2d 9, 577 P. 2d 975 (1978) (Dalkon Shield IUD); Lunt v. Mount Spokane Skiing Corp., 62 Wn. App. 353, 814 P.2d 1189 (1991).
[8] 389 P.3d at 524.
[9] 389 P.3d at 525.
[10] 389 P.3d at 526-27.
[11] 389 P.3d at 527-28.
[12] 389 P.3d at 528.