Moving Beyond The Learned Intermediary Doctrine
By Michelle L. Cheng and Sevana Zadourian, Reed Smith LLP
In addition to a duty to warn doctors of dangers presented by the medical devices they prescribe, manufacturers of highly sophisticated medical devices may be subject to an additional duty to warn hospitals – as the product purchasers – when such devices are sold in the state of Washington. In the recent decision, Taylor v. Intuitive Surgical, Inc, 389 P.3d 517 (Wa. 2017) — a case involving a robotic surgical device used to perform laparoscopic surgeries — the Supreme Court of Washington examined the Washington Product Liability Act (WPLA) and concluded that the statute “impose[d] a separate and distinct duty for the manufacturer to provide warnings to the purchaser of the product.”
For medical device manufacturers, it is of critical importance going forward to limit the import of this decision to the factually unique reasons compelling the Court’s decision in this case.
Taylor And Duties To Warn
The medical device at issue in Taylor was the da Vinci Surgical System, used by surgeons during laparoscopic surgeries, such as prostatectomies (an operation to remove part or all of the prostrate). The FDA cleared the system for use by surgeons who are specially credentialed to operate it and, because of its complexity, even surgeons with expertise in open surgery still were required to undergo “training and experience to operate the da Vinci System successfully.” Experts testified that “confidence” with the device was not achieved until a surgeon had completed 150-250 procedures with it.
In addition to the manufacturer’s own requirement that surgeons perform two proctored surgeries before using the da Vinci system, hospitals enforced their own requirements for credentialing surgeons before permitting them to use it. The manufacturer provided a user’s manual intended specifically for doctors operating the da Vinci, and it contained a number of warnings related to the device. Relevant here is the manufacturer’s advice that prostatectomies should not be performed on obese patients, prostrate surgeries should not be performed on patients who previously underwent lower abdominal surgeries, and patients should be placed in a steep Trendelenburg positon (body laid flat on the back, with the feet higher than the head by 15-30 degrees) during the procedure.
In Taylor, all three of these warnings went unheeded: the patient was obese, had three prior lower abdominal surgeries, and was not positioned in the steep Trendelenburg position during the procedure. The doctor knew Mr. Taylor “was not an optimal candidate,” but he still performed the prostatectomy as his first unproctored procedure using the da Vinci system. Taylor alleged that his surgery was unsuccessful, resulted in a poor quality of life, and, roughly four years after the surgery, he passed away. Mr. Taylor (and later his surviving spouse) sued the doctor, his medical practice, the hospital, and the da Vinci system’s manufacturer, Intuitive Surgical, Inc. (ISI).
All parties ultimately settled, except for ISI. On summary judgement, nearly all claims were dismissed, except for the failure to warn claim against ISI. This failure to warn claim proceeded to trial, where a jury determined that ISI was not negligent in providing instructions and warnings to the learned intermediary – the surgeon who used the da Vinci system for Mr. Taylor’s surgery. The Taylors appealed the decision, assigning multiple errors to the trial court, but the question remains: Did ISI have a duty to warn the hospital, as purchaser of the da Vinci system?
Upon appeal, the Supreme Court of Washington vacated and remanded the judgment, finding that (1) under the WPLA, manufacturers had a duty to warn hospitals, and (2) merely warning the learned intermediary – the surgeon – did not excuse ISI’s duty to warn the hospital.
[Editor's Note: Following publication of this article, Intuitive Surgical Inc. contacted Med Device Online, via email, with the following statement: "The Washington Supreme Court fails to note in its ruling that Intuitive Surgical presented evidence at trial showing that, consistent with our usual practice, we delivered the hospital’s da Vinci System with the user manual, which includes warnings and precautions about the device."]
Relevant to this decision, the statute — RCW 7.72.030(1) — states:
(b) A product is not reasonably safe because adequate warnings or instructions were not provided with the product, if, at the time of manufacture, the likelihood that the product would cause the claimant's harm or similar harms, and the seriousness of those harms, rendered the warnings or instructions of the manufacturer inadequate and the manufacturer could have provided the warnings or instructions which the claimant alleges would have been adequate.
Although the Court recognized that the WPLA did not specify who should receive product warnings, it recognized that the language contemplated warnings provided both with the product and to “product users.” Taking this logic further, the Court interpreted the statute to include purchasing hospitals, because by owning and maintaining the product, they are entitled to receive warnings with the product. The Court stated that, because the da Vinci System is an “extremely complex and inherently dangerous medical device,” hospitals required warnings to satisfy their independent duty of care to their patient (i.e., to design a credentialing process that would encompass the warnings necessary for surgeons to use the device properly).
The Court explained that, because the hospitals are in a superior position to “monitor and control physician performance,” a “doctrine of corporate negligence” could be imposed, thus “requiring them to assume responsibility would provide hospitals a financial incentive to insure the competency of their medical staffs.” [citing Pedroza v. Bryant, 101 Wash.2d 226 (1984)].”
Furthermore, the Court held that the learned intermediary doctrine did not apply to Taylor. Ordinarily, under the learned intermediary doctrine, a medical device manufacturer may alleviate its duty to warn the patient about a prescription device by warning the physician. This has been upheld in a number of cases, including Terhune v. A. H. Robins Co., 90 Wash. 2d 9, 14 (1978), Seifried v. Hygenic Corp., 410 S.W.3d 427, 432 (Tex. App. 2013), and Banker v. Hoehn, 278 A.D.2d 720, 721 (N.Y. App. Div. 2000).
In Taylor, the Court determined that the doctrine merely allows manufacturers to satisfy their duty to warn the consumer by communicating warnings to the doctor; the manufacturer’s duty to warn the hospital was not fulfilled when it warned the learned intermediary.
Duty To Warn Hospitals
While the Court in Taylor approached the medical device manufacturer’s duty to warn in a novel way, based on the statutory language and existing law imposing a duty of care on hospitals, at least two other state courts also have acknowledged a duty to warn hospitals. However, they have treated hospitals as learned intermediaries, versus imposing a separate duty to warn hospitals.
In Seifried v. Hygenic Corp., for example, the Texas Court of Appeals found that the manufacturer’s duty to warn extended to the hospital as the intermediary. The Court held, “[a]ccordingly, we conclude that Hygenic's duty to warn extended to the intermediary, the Hospital, and not the ultimate user of the resistance band, the patient.” In this case, unlike Taylor, the reviewing court held that the manufacturer had a duty to warn the hospital because the hospital also was an intermediary. The hospital and the physical therapist monitored and supervised the patient in his/her use of the product, and the hospital was in better position than the manufacturer to warn about potential harm resulting from the product.
Similarly, in Brown v. Drake-Willock Int'l, Ltd. (1995), 209 Mich. App. 136, 149 (1995), the Michigan Court of Appeals held that the manufacturer had no duty to warn the patient about the use of formaldehyde to clean a dialysis machine because, under the learned intermediary rule, the hospital or the physician could be the proper recipient of necessary information or warnings.
Thus, while some courts have ventured so far as to say that a hospital also is an “intermediary,” along with its doctors, no other state has imposed an independent duty for manufacturers to also warn the hospital.
Limiting Taylor
Medical device manufacturers may be best served if the scope of this decision is limited to situations where the hospital holds some role in gatekeeping use of the device (i.e., the credentialing process) and maintains the device on the premises — for example, a surgical robot versus single-use devices or implants that leave the hospital with the patient. Still, in cases where medical device manufacturers distribute products for which hospitals must provide their doctors with additional training, credentialing, or other support, the manufacturers should be mindful whether it is their duty to warn the hospital (in lieu of, or in addition to, doctors using the product) of risks associated with use.
About The Authors
Michelle L. Cheng is a senior litigation associate at Reed Smith LLP, and she regularly represents medical device and pharmaceutical manufacturers in product liability and commercial disputes.
Sevana Zadourian is with Reed Smith LLP in the Los Angeles office.