Artificial intelligence (“AI”) will likely drive many complex medical devices in the near future. But as with all things, AI can sometimes fail. Companies relying on AI to elevate their medical devices above the competition should be mindful of four common AI failure modes: AI functional errors, software rot, unexplained programming glitches, and the ever-present human factor.
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Intuitive Surgical
Europe’s New Proposed Rules for Artificial Intelligence and Robot-Assisted Surgery
This week, the European Commission unveiled new proposed rules “aiming to turn Europe into the global hub for trustworthy” artificial intelligence. The 108-page first-of-its-kind policy outlines how companies and governments should use artificial intelligence, and sets “limits around the use of artificial intelligence in a range of activities, from self-driving cars to hiring decisions, bank lending, school enrollment selections and the scoring of exams.” Importantly, the proposed rules also directly impact artificial intelligence application in robot-assisted surgery.
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Surgical Robots Risk Greater Legal Costs Than You May Think
It’s no secret that defending against product liability lawsuits can be costly. But surgical robot manufacturers sometimes ask me to give them hard numbers. To read the tea leaves and estimate how much they’ll have to spend to resolve such claims. Unfortunately, the answer is hard to swallow.
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Now That Your Surgical Robot Has Hit the Market, When Will the Lawsuits Start?
Death and taxes are unavoidable. And if you create a popular product, so too are product liability lawsuits. In my practice, companies sometimes ask, “How soon after our surgical robot hits the market will we get sued?”
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The FDA’s Latest Warning: A Good Reminder Regarding the Litigation Risks of Off-Label Use
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?
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Emerging Trends in Surgical Robotics Product Liability Litigation
Over the last decade, robotics have revolutionized healthcare. Surgical robots are rapidly making their way into many of our nation’s operating rooms, and are being used in a wide variety of surgeries ranging from gynecological to ocular procedures. Their popularity stems not only from their relative ease of use, but also from their potential for improved patient outcomes and decreased recovery time.
As with any device or product, however, surgical robots and the companies that make them have not been immune from product liability lawsuits.
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Lessons Learned From the Intuitive Surgical Lawsuits: Physician Learning Curves
As I noted last month, surgeon training is one of the issues that was debated in the various product liability lawsuits that were filed against Intuitive Surgical in recent years. This begs the question: How much training should a surgeon complete before being handed the keys to a surgical robot?
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Lessons Learned From the Intuitive Surgical Lawsuits: The Benefits of Partnering With Independent Educational Firms
Though a number of companies manufacture and sell surgical robots in the United States, Intuitive Surgical has been the primary target of product liability lawsuits in recent years. Around 100 such claims have already been filed and at least 700 more are believed to have been placed on the back burner pursuant to a tolling agreement with some plaintiffs’ counsel. To date, only two product liability cases against Intuitive have gone to trial. The jury returned a defense verdict in the first case and the second was settled while the jury was deliberating. These cases serve as a great source of important takeaways for other companies that are either currently selling surgical robots in the United States, or are considering doing so.
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Five Steps Robotic Manufacturers Can Take to Limit Liability When Using 3-D Printing
Clinical robotics and other emerging technologies are profoundly reshaping the way in which medicine is practiced. One of those technologies, additive manufacturing—also known as 3-D printing—is helping usher in a new era of innovation and customization unlike anything that we have ever seen. But with this promising innovative technology also come many novel challenges, as both the industry and the law try to keep up with new developments. As 3-D printing becomes more widely adopted in the clinical robotics arena, an important question arises: What steps can traditional manufacturers take to lessen or eliminate their potential liability when using 3-D printing in the production process?
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As New Players Enter the Robotic Surgery Field, the Legal Implications are Limitless
Varun Saxena from Fierce Medical Devices recently reported that partners Johnson & Johnson and Google are designing their own robotic surgery devices, which “will compete with Intuitive in general surgery arenas, which include hernia repair and colorectal surgery.” The Johnson & Johnson endeavor was formed in collaboration with Google’s Verily Life Sciences and will operate under the name Verb Surgical Inc..
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