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Mihai Vrasmasu is a Partner in the Miami office of Shook, Hardy & Bacon. He represents multiple clients—including Fortune 100 pharmaceutical and medical device manufacturers—facing complex product liability claims involving medical devices and prescription drugs.

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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Recently, my colleague Amy Foust made some really good points about a subject that is rarely discussed.  Over the years, a number of patients have claimed that they were injured by surgical robots defective by design or manufacture.  A recent study from Johns Hopkins University may now allow some to argue that surgical robots are also injuring surgeons. 
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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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It’s not hard to imagine a time in the not-too-distant future when physicians start using 3-D printing technology to produce tools for their robotic surgery systems that are based on existing copyrighted models but customized to address patient-specific needs. But what happens when the copyright holders of those existing models start attributing depressed bottom lines

In January, I posted regarding the impact of the Florida Supreme Court’s decision in Aubin v. Union Carbide Corp., 177 So. 3d 489 (Fla. 2015).  In that post I explained that even after Aubin, the consumer expectations test should not be applied in all design defect strict product liability cases because it is still up to the individual trial court judges to decide whether the consumer expectations and risk-utility tests should be given alternatively or together depending on the individual circumstances presented in each case. Some of the reasons for this conclusion included that the standard jury instructions remain unchanged; that numerous courts have ruled some products are too complex for the application of the consumer expectations test; that cases subject to the learned intermediary doctrine by definition involve a product too complex to permit the application of the consumer expectations test; and that the risk-utility test traces its roots to the Restatement (Second) of Torts, not the Restatement (Third) of Torts which was rejected in Aubin.
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YouTube is a great educational resource. By watching a few videos, one can learn just about anything, from how to tie a fancy knot to how to assemble an internal combustion engine. The website also features numerous videos concerning various do-it-yourself medical procedures. Recently, my colleague Amy Foust and I viewed a fascinating video about an inexpensive surgical robot built by Designer Frank Kolkman using off-the-shelf components and easily accessible technologies like 3-D printing and laser cutting. This got us thinking: Is do-it-yourself surgery using homemade robots really a good idea?
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