Photo of Mihai Vrasmasu

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.

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?

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?
Continue Reading The FDA’s Latest Warning: A Good Reminder Regarding the Litigation Risks of Off-Label Use

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. 
Continue Reading Emerging Trends in Surgical Robotics Product Liability Litigation

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. 
Continue Reading Can Robot-Assisted Surgery Be a Pain?

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?
Continue Reading Lessons Learned From the Intuitive Surgical Lawsuits: Physician Learning Curves

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.
Continue Reading Lessons Learned From the Intuitive Surgical Lawsuits: The Benefits of Partnering With Independent Educational Firms

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