Manufacturers of Medical Supplies Must Warn Purchasers of Potential Risks
From the desk of Kyle Riley: Washington’s products liability act requires manufacturers to warn consumers about the risks of their products. But when the manufacturer of a medical device has provided warning to the product user—the physician—does it also have a duty to warn the hospital that purchased the product? Read on to find out.
Claims Pointer: In this case arising out of surgical complications that resulted in a loss of quality of life and ultimately the death of the patient, the Washington Supreme Court held that the manufacturer did have a duty to warn the hospital of risks associated with the product. This case provides important insight into the scope of the manufacturer’s duty to warn, especially in the medical context.
Taylor v. Intuitive Surgical, Inc., No. 92210-1, Washington Supreme Court (February 9, 2017)
Intuitive Surgical, Inc. (“ISI”) manufactures a robotic surgical device called the “da Vinci System.” Surgeons use the device to perform minimally invasive robotic laparoscopic surgeries. The device requires training and experience to operate it correctly, even for surgeons with expertise in open surgery. ISI accordingly requires that surgeons perform two proctored surgeries, and hospitals also enforce their own requirements for credentialing surgeons to use the device. ISI also recommends that surgeons choose simple cases for initial unproctored procedures and ISI provides a user’s manual to doctors containing various warnings related to the device. Three ISI warnings are particularly relevant: (1) not to perform prostatectomies on obese persons (guidelines stated that patients should have a body-mass index (“BMI”) below 30; (2) not to perform prostate procedures on persons who previously underwent lower abdominal surgeries; and (3) that patients should be in a steep Trendelenburg position (tilted with head downward) during the procedure.