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 More recently, FDA released a complementary draft guidance.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
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
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
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
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.