Type: Articles Published
For medical device manufacturers, it is of critical importance going forward to limit the import of this decision to the factually unique reasons compelling the Court’s decision in this case.
Taylor And Duties To Warn
The medical device at issue in Taylor was the da Vinci Surgical System, used by surgeons during laparoscopic surgeries, such as prostatectomies (an operation to remove part or all of the prostrate). The FDA cleared the system for use by surgeons who are specially credentialed to operate it and, because of its complexity, even surgeons with expertise in open surgery still were required to undergo “training and experience to operate the da Vinci System successfully.” Experts testified that “confidence” with the device was not achieved until a surgeon had completed 150-250 procedures with it.
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