Mihai Vrasmasu

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

By Mihai Vrasmasu

April 7, 2020

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…

Clinical Robotics Law Journal

Now That Your Surgical Robot Has Hit the Market, When Will the Lawsuits Start?

By Mihai Vrasmasu

February 25, 2020

Death and taxes are unavoidable. And if you create a popular product, so too are product liability lawsuits. In my practice, companies sometimes ask, “How soon after our surgical robot hits the market will we get sued?”…

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

By Mihai Vrasmasu

March 7, 2019

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 …

Clinical Robotics Law Journal

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

By Mihai Vrasmasu

March 7, 2019

Clinical Robotics Law Journal

The Healing Touch: Haptic Feedback and the State-of-the-Art Defense

By Mihai Vrasmasu

February 20, 2019

As more and more surgical robots make their way into operating rooms, companies are learning valuable lessons about how their devices function in the real world. Though many existing design features are proving highly effective, physician response suggests that current systems should evolve to include additional capabilities, like “haptic feedback.” While discussing what it’s like to perform surgery without it, a UCLA associate professor of electrical engineering recently explained, “You can see what you’re doing, …

Clinical Robotics Law Journal

Emerging Trends in Surgical Robotics Product Liability Litigation

By Mihai Vrasmasu

January 14, 2019

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…

Clinical Robotics Law Journal

Can Robot-Assisted Surgery Be a Pain?

By Mihai Vrasmasu

June 7, 2017

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. …

Clinical Robotics Law Journal

Lessons Learned From the Intuitive Surgical Lawsuits: Physician Learning Curves

By Mihai Vrasmasu

February 28, 2017

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?…

Clinical Robotics Law Journal

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

By Mihai Vrasmasu

January 30, 2017

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…

Clinical Robotics Law Journal

Shielding Intellectual Property from 3-D Printing’s Paradigm Shift

By Mihai Vrasmasu

December 22, 2016

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 to unauthorized 3‑D printing? Jesse Camacho and I published an article in Industry Week addressing the issue of how copyright holders…

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

Now That Your Surgical Robot Has Hit the Market, When Will the Lawsuits Start?

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

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

The Healing Touch: Haptic Feedback and the State-of-the-Art Defense

Emerging Trends in Surgical Robotics Product Liability Litigation

Can Robot-Assisted Surgery Be a Pain?

Lessons Learned From the Intuitive Surgical Lawsuits: Physician Learning Curves

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

Shielding Intellectual Property from 3-D Printing’s Paradigm Shift

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