Photo of Mihai Vrasmasu

Mihai Vrasmasu is a Partner in the Miami office of Shook, Hardy & Bacon. He represents multiple clients—including Fortune 100 pharmaceutical and medical device manufacturers—facing complex product liability claims involving medical devices and prescription drugs.

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

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

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

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

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

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

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