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
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 More recently, FDA released a complementary draft guidance. Continue Reading FDA’s New Draft Guidance on Postmarket Cybersecurity Programs for Medical Devices
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 immediately, a number of commentators argued that Aubin spelled the end of the exclusive application of the risk-utility test in all Florida cases involving strict liability design defect claims. But is that really true? Continue Reading Following Aubin v. Union Carbide, Will Complex Medical Device Manufacturers Face an Uphill Battle in Defending Against Strict Liability Design Defect Claims in Florida?
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?
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? Continue Reading Robots in Permission-based Occupations
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?
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 Intuitive Surgical Invests in Robotic-Assisted Surgery 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.