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

YouTube is a great educational resource. By watching a few videos, one can learn just about anything, from how to tie a fancy knot to how to assemble an internal combustion engine. The website also features numerous videos concerning various do-it-yourself medical procedures. Recently, my colleague Amy Foust and I viewed a fascinating video about an inexpensive surgical robot built by Designer Frank Kolkman using off-the-shelf components and easily accessible technologies like 3-D printing and laser cutting. This got us thinking: Is do-it-yourself surgery using homemade robots really a good idea?
Continue Reading The Do-It-Yourself Surgery Genie is About to Escape the Bottle

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?
Continue Reading Will the Rise of the Machine Mark the Fall of Med Mal?

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 both the industry and the law try to keep up with new developments.  As 3-D printing becomes more widely adopted in the clinical robotics arena, an important question arises: What steps can traditional manufacturers take to lessen or eliminate their potential liability when using 3-D printing in the production process?
Continue Reading Five Steps Robotic Manufacturers Can Take to Limit Liability When Using 3-D Printing

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 under the name Verb Surgical Inc.
Continue Reading As New Players Enter the Robotic Surgery Field, the Legal Implications are Limitless

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 allegations are made that raise eyebrows and leave even the most experienced litigator scratching her head.  In August of this year, Intuitive Surgical was named as a defendant in a case venued in Miami-Dade County, Florida, involving the da Vinci Si HD Surgical System.  See Seinfeld v. Intuitive Surgical, Inc., No. 2015-018171-CA-01. And this is one of those eyebrow-raising cases.
Continue Reading Can a Complex Medical Device Require Too Much Training?

My colleague, Amy Foust, and I were recently discussing steps that medical device manufacturers can take to limit liability before a system security breach occurs. As if medical device companies didn’t have enough to worry about, the news this year has been replete with stories about software vulnerabilities and successful hacks of medical devices with integrated operating software.
Continue Reading How Secure is Your Medical Device?