Tag Archives: Intuitive Surgical

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

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.” … Continue Reading

Emerging Trends in Surgical Robotics Product Liability Litigation

By Mihai Vrasmasu on January 14, 2019 Posted in Litigation, Surgical Robot, Training

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 … Continue Reading

Lessons Learned From the Intuitive Surgical Lawsuits: Physician Learning Curves

By Mihai Vrasmasu on February 28, 2017 Posted in Industry Insights, Litigation, Surgical Robot, Training

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: The Benefits of Partnering With Independent Educational Firms

By Mihai Vrasmasu on January 30, 2017 Posted in Industry Insights, Litigation, Surgical Robot, Training

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 … Continue Reading

Five Steps Robotic Manufacturers Can Take to Limit Liability When Using 3-D Printing

By Mihai Vrasmasu on March 30, 2016 Posted in 3-D Printing, Litigation, Surgical Robot

Clinical robotics and other emerging technologies are profoundly reshaping the way in which medicine is practiced. One of those technologies, additive manufacturing—also known as 3-D printing—is helping usher in a new era of innovation and customization unlike anything that we have ever seen. But with this promising innovative technology also come many novel challenges, as … Continue Reading

As New Players Enter the Robotic Surgery Field, the Legal Implications are Limitless

By Mihai Vrasmasu on December 21, 2015 Posted in Industry Insights, Litigation, Surgical Robot

Varun Saxena from Fierce Medical Devices recently reported that partners Johnson & Johnson and Google are designing their own robotic surgery devices, which “will compete with Intuitive in general surgery arenas, which include hernia repair and colorectal surgery.” The Johnson & Johnson endeavor was formed in collaboration with Google’s Verily Life Sciences and will operate … Continue Reading

Can a Complex Medical Device Require Too Much Training?

By Mihai Vrasmasu on November 24, 2015 Posted in Litigation, Surgical Robot, Training

When filing their complaints, plaintiffs’ lawyers usually take the shotgun approach and throw in as many boilerplate allegations as they can think of. Oftentimes, many of these claims are easily disposed of by way of a motion either to dismiss or to strike, or later on down the road through dispositive briefing. But sometimes, certain … Continue Reading

Intuitive Surgical Invests in Robotic-Assisted Surgery Training

By Mihai Vrasmasu on August 4, 2015 Posted in Industry Insights, Studies, Surgical Robot, Training

Hot off the heels of a recent study linking robotic surgery to negative patient outcomes, Intuitive Surgical—the global leader in robotic-assisted, minimally invasive surgery, and manufacturer of the da Vinci® Surgical System—announced that it “awarded simulator grants to five top U.S. medical centers to advance the field of training for robotic-assisted minimally invasive surgery.”… Continue Reading

Is Robotic Surgery Getting a Bad Rap?

By Mihai Vrasmasu on July 30, 2015 Posted in Litigation, Studies, Surgical Robot, Training

A recent study and a growing number of lawsuits would have us believe that injuries and deaths during robotic surgery are due to failures with the robotic devices. But there is much more to those claims than meets the eye.… Continue Reading