Recently, my colleagues Colin Kelly, Caroline Gieser, Michael Polatsek, and I thought about the role that additive manufacturing (3D-printing) is playing in today’s brave new world.  As COVID-19 continues to cause critical manufacturing shortages while also increasing demand for emergency medical and protective equipment, the government and private industry are coming together with the help of 3D-printing technology to tackle both problems simultaneously. Manufacturers large and small are arming themselves with 3D-printing to produce much-needed medical and protective products that are in high demand but short supply. The list of critical COVID-19-related products being manufactured through 3D-printing include nasal swabs, ventilators, face shields, gowns, masks and even respirators. Yet additive manufacturing is still a relatively new process and certain technical and practical limitations remain. Indeed, as the U.S. Food and Drug Administration (FDA) noted in a March 26, 2020, communication, “3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators.”

Up until very recently, discussions about the risks associated with 3D-printing have been mostly hypotheticals reserved for academics and product liability lawyers, but COVID-19 has now raised the question: Will well-intentioned additive manufacturers (large and small) face personal injury claims for helping address COVID-19-related spikes in demand for medical and protective equipment?
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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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Recently, James Ryan Morales from HealthAim reported on a new study at Children’s National Medical Center in Washington involving the Smart-Tissue Autonomous Robot (STAR) Project. In the study, a supervised autonomous robot performed soft-tissue surgery on a pig’s bowel, demonstrating that robots can now perform surgical operations with very minimal human supervision. It is, therefore, only a matter of time before fully autonomous surgical robots make their way into operating rooms across the country. And so, this begs the question: Will patients still be able to sue their human physicians for injuries allegedly sustained while under an autonomous surgical robot’s scalpel?
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