Understanding a Medical Device Manufacturer's Broad Duty to Warn

April 13, 2017

Medical Device and Diagnostic Industry

Washington State’s highest court set off a bit of a firestorm recently when it ruled that medical device manufacturers must warn those who buy their products about related risks. The court’s decision in Taylor v. Intuitive Surgical, Inc., seemed to undermine the customary view that a device manufacturer need only provide its warnings to the prescribing physician; the learned intermediary. A broader review of the law shows that the court may not have strayed too far from basic product liability concepts and provides a good opportunity for medical device manufacturers to review their approach to product warnings.   

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“Understanding a Medical Device Manufacturer's Broad Duty to Warn,’” by Terry M. Henry, Melanie S. Carter, Lauren E. O’Donnell, and Naomi Zwillenberg was published in DeviceTalk, a Medical Device and Diagnostic Industry blog, on April 13, 2017.