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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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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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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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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When filing their complaints, plaintiffs’ lawyers usually take the shotgun approach and throw in as many boilerplate allegations as they can think of.  Oftentimes, many of these claims are easily disposed of by way of a motion either to dismiss or to strike, or later on down the road through dispositive briefing.  But sometimes, certain allegations are made that raise eyebrows and leave even the most experienced litigator scratching her head.  In August of this year, Intuitive Surgical was named as a defendant in a case venued in Miami-Dade County, Florida, involving the da Vinci Si HD Surgical System.  See Seinfeld v. Intuitive Surgical, Inc., No. 2015-018171-CA-01. And this is one of those eyebrow-raising cases.
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Hot off the heels of a recent study linking robotic surgery to negative patient outcomes, Intuitive Surgical—the global leader in robotic-assisted, minimally invasive surgery, and manufacturer of the da Vinci® Surgical System—announced that it “awarded simulator grants to five top U.S. medical centers to advance the field of training for robotic-assisted minimally invasive surgery.”
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