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# Court Extends Device Duty to Warn
- URL: https://www.fdaweb.com/court-extends-device-duty-to-warn/
- Published: 2017-07-11T12:00:00.000Z
- Updated: 2026-09-14T22:33:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139110

The Washington Supreme Court has held that a medical device manufacturer has a duty to warn hospitals, and not just doctors, about the potential dangers of a device. A Washington Legal Foundation *Legal Opinion Letter* [says](http://wlf.org/upload/legalstudies/legalopinionletter/063017LOL%5FMiller.pdf?ref=fdaweb.com) the decision “represents a significant and unwarranted expansion of the duty to warn under Washington’s product liability law.”

The case, *Taylor v. Intuitive Surgical, Inc.,* involves an Intuitive Surgical robotic device used in laparoscopic surgery. Warnings about the device in a users manual said it should not be used to perform prostate surgery on obese patients, that it should not be used for prostate surgery on patients who had previously undergone lower abdominal surgery, and that patients should be tilted with their head downward during the procedure.

The suit arose from prostate surgery performed by a Bremerton, Washington, doctor on a man who weighed 280 pounds, had had three prior lower abdominal surgeries, and could not be positioned with his head tilted down due to his weight. The patient said he suffered serious complications, including neuromuscular damage that prevented him from walking without assistance. He died four years later, partly due to the complications.

The patient sued the doctor, the hospital, and Intuitive Surgical. He settled with the doctor and the hospital. The trial court granted summary judgment in favor of the company on all claims except for a claim that the company had violated the Washington Product Liability Act by failing to give an adequate warning on the risks of its device. That claim went to a jury trial that returned a verdict in favor of the company.

The WLF publication says that on appeal, the Washington Supreme Court reversed the lower court ruling in a 6-3 decision. The court held that the trial court erred in failing to instruct the jury that the company had a duty to warn the hospital and not just the doctor of the risks associated with the device.

The majority opinion does not explain how providing a warning to the hospital could realistically have helped the patient, writes **Eric Miller** (Perkins Cole), the author of the WLF letter. “The purpose of a warning, after all,” he says, “is to make sure that the product is reasonably safe when used. Providing a warning to the product’s users helps to promote safety; however, giving a warning to others in the chain of distribution does not. In the case of medical devices, the user is the physician employing (or prescribing) the device.”

Miller says that the learned intermediary doctrine takes account of the reality that doctors are the device users and thus it would not make sense to require a manufacturer to give warnings directly to patients because an adequate warning would have to contained detailed technical information that would not be meaningful to laypeople. Similarly, he says, warning hospitals makes little more sense. While the court found that hospitals make decisions about which products to purchase and which doctors should have privileges to perform procedures, he says, they do not have the same role as doctors in treating patients. Thus, hospitals don’t know what kind of surgery might be appropriate for a given patient or when it might be appropriate to use a specific medical device.

“It is difficult to see how patients will benefit from thrusting hospitals into a more intrusive supervisory role,” Miller concludes. “To the contrary, the rule adopted in *Taylor* may harm patients in the long run by discouraging the development and use of new medical devices that are beneficial despite their inherent risks. More broadly, the logic of *Taylor* suggests that manufacturers may have a duty to warn intermediate purchasers of other inherently dangerous products, not just medical devices. It remains to be seen how far the Washington Supreme Court will extend the decision, but it portends an overly broad expansion of product liability law.”