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…

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…

A couple of years ago, the FDA articulated its expectations for the ways device manufacturers should address cybersecurity premarket. More recently, FDA released a complementary draft guidance.…

In Florida, there are two tests that a jury may apply in determining whether a product is defectively designed under a strict liability theory: the “consumer expectation test” and the “risk-utility test.”  Plaintiffs usually prefer the consumer expectation test because it is generally easier for them to prove, while defendants prefer the “risk-utility test.”  Late last year, the Florida Supreme Court issued its opinion in Aubin v. Union Carbide Corp., 177 So.3d 489 (Fla. 2015).  Almost…

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.. …

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…

Recently, my colleagues Jim Muehlberger and Chris Wray made some really good points about robots functioning in permission-based occupations.  Does the law permit a robot to serve as your cosmetologist?  What about as your surgeon?  …