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Mihai Vrasmasu

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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.

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When most people think about product liability lawsuits involving surgical robots, they imagine the scenario where a patient undergoes an unsuccessful operation and then sues the robot manufacturer for damages. But few envision claims against robot manufacturers for injuries sustained by healthcare providers while using surgical robots. So what would such a claim look like?  And what steps can surgical robot manufacturers take to mitigate their exposure?Continue Reading Surgical Robot End User v. Manufacturer

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.
Continue Reading 4 Common Ways That AI Driven Medical Devices Can Fail

Today, major healthcare companies are investing heavily into various AI-powered devices. For example, Zimmer Biomet and the New York City-based Hospital for Special Surgery recently inked a three-year deal to create the HSS/Zimmer Biomet Innovation Center for Artificial Intelligence in Robotic Joint Replacement. “The collaboration aims to develop decision support tools—powered by data collection and machine learning — to assist surgeons planning and predicting outcomes for robotic-assisted joint replacements.” Additionally, Johnson & Johnson have gone on record saying that they see “a huge opportunity to harness data, machine learning and artificial intelligence to help drive decision-making at all levels of healthcare.” As artificial intelligence starts playing a larger role in the modern healthcare space, a critical question will need to be answered: Are AI-powered solutions products or services?
Continue Reading Is Your Artificial Intelligence a Service or a Product?

During product development, it’s not unusual to discover certain failure points in a surgical robot’s design. For example, certain components, like nuts or bolts or screws, may become brittle when exposed to various substances or gasses commonly found in operating rooms. Similarly, prolonged use may cause cables and wires to become overstressed. Such component degradation may result in unwanted changes in the robot’s movement patterns or even complete structural failure. Issues like these, if not immediately addressed during product development, can become low-hanging fruit for plaintiffs’ lawyers.
Continue Reading Defeat Design Defect Claims Before They’re Filed

Until they become fully autonomous, surgical robots will only be as good as their human operators. Training for all surgeons, nurses, bedside assistants, and other surgical team members is critical to ensuring optimal patient outcomes. Thus, many manufacturers ask surgical staff to undergo instruction and demonstrations on how to set up, handle, and operate their systems. Such training can span several days and often includes simulations, scenario role-playing, and hands-on time with the robot. But what should a robot manufacturer do when asked by healthcare providers to modify its training curriculum and change certain important elements like course length, course content, or attendee roles and numbers?
Continue Reading Mitigating The Risks Of Training Curriculum Modification Requests

Recently, an artificial intelligence-guided robot successfully performed a laparoscopic surgery to connect two ends of an intestine in four pigs, without any human intervention. And according to the researchers involved, the robot surgeon produced “significantly better” results than humans. Though such an accomplishment is astonishing and signals the inevitable rise of fully autonomous medical robots, it is important to remember that the results generated by artificial intelligence are only as good as the information used to train it.
Continue Reading The Risk of Clinical Data Collection Biases In Fully Autonomous Medical Robots

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.
Continue Reading Europe’s New Proposed Rules for Artificial Intelligence and Robot-Assisted Surgery

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.
Continue Reading Surgical Robots Risk Greater Legal Costs Than You May Think

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?
Continue Reading COVID-19: Will 3-D Printing Medical Supplies and Protective Products Expose You to Liability?