Last week, the FDA issued a warning against the use of robotic surgery for mastectomy and other cancer-related procedures. The warning stated, in relevant part, “To date, the FDA has not granted marketing authorization for any robotically-assisted surgical device for use in the United States for the prevention or treatment of cancer, including breast cancer.” The warning went on to say, “Be aware that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established.” This action came after the Agency reviewed certain literature suggesting that robotically assisted devices were being used “off-label” in cancer treatment. Incidents like this raise a very important question: How can a company avoid or minimize liability in the event of off-label use?
Continue Reading The FDA’s Latest Warning: A Good Reminder Regarding the Litigation Risks of Off-Label Use
