Expanding Duties And Eroding Protections For Medical Device Manufacturers

Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions from strict liability afforded to manufacturers of certain "unavoidably unsafe" products.¹  This decision comes as a surprise and represents an unexpected shift in the law with regard to medical device manufacturers.

Background 

Intuitive Surgical, Inc. (Intuitive) manufactures and markets the da Vinci System robotic device—a device that has been used for robotic laparoscopic surgeries for nearly two decades.  Due to its complexity, the da Vinci System may only be used by credentialed surgeons.