​A medical device manufacturer has a legal duty to warn hospitals, as purchasers of products, about the products' dangers, and a manufacturer's warning to physicians, as users of such products, does not excuse the manufacturer from warning the hospital purchaser, the Supreme Court of Washington State held. In its ruling, the court clarified the duties of product manufacturers pursuant to the state's product liability act. The act closely mirrors § 402A of the Restatement (Second) of Torts, a legal treatise of American law adopted by many jurisdictions in state statutes as well as case law. The court rejected the application of the "learned intermediary" doctrine cited by an appellate court in this case to exonerate the manufacturer. Overruling the appeals court, the supreme court held that physicians, as users of medical devices, do not function as intermediaries between the device manufacturer and a hospital purchaser. "If patient safety is the goal, then it requires all hands on deck," the court wrote. The court characterized the hospital as the "gatekeeper" between the physician and the user of the device because the hospital clears surgeons to use it, the court explained. At issue in the wrongful death case against a hospital, a surgeon, and a medical device maker was a robotic surgery system. The defendant surgeon used the device to assist him in performing a minimally invasive prostate surgery procedure. The case was the surgeon's first nonproctored use of the device, after he was credentialed to use it. During the procedure, the patient's rectal wall was lacerated. Another surgeon had to step in to repair the damage through open surgery. The resulting significant complications allegedly hastened the patient's death. The surgeon settled the case before trial, which proceeded against the hospital and manufacturer. The jury exonerated the manufacturer, following the court's legal instruction that the manufacturer had no duty to warn the hospital of the hazards of the device, and that the manufacturer's warnings to surgeons, as users of the device, were legally sufficient. The plaintiff appealed and lost, further appealing to the state's highest court. The high court concluded that a hospital's knowledge of the risks of the robotic surgery system was necessary in order to allow the hospital to impose stricter credentialing processes. A 2013 Wall Street Journal article discussed risks of the device (see HRC Alerts, November 13, 2013). A previous issue of HRC Alerts discussed the case with regard to credentialing physicians for new technologies (see HRC Alerts, April 14, 2015).

(Source: Taylor v. Intuitive Surgical (Wash Sup. Ct. No. 92210-1) Feb 9, 2017.)

HRC Recommends: Healthcare facilities that credential surgeons to perform robotic-assisted surgery should be aware of the risks of the device as stated by the manufacturer. Robotic-assisted surgery requires surgeons to learn new surgical skills and, along with the operating room team, to operate new equipment. Healthcare organizations' device training, proctoring, and credentialing requirements must address the skills needed to perform robotic-assisted procedures and provide a measure to assess the surgeon's skill acquisition and proficiency. Healthcare organizations should also establish metrics to gauge the surgeon's ongoing proficiency and to monitor patient outcomes.