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
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
It’s not hard to imagine a time in the not-too-distant future when physicians start using 3-D printing technology to produce tools for their robotic surgery systems that are based on existing copyrighted models but customized to address patient-specific needs. But what happens when the copyright holders of those existing models start attributing depressed bottom lines to unauthorized 3‑D printing?
Jesse Camacho and I published an article in Industry Week addressing the issue of how copyright holders could push back to regain control over their intellectual property. In our analysis, we looked all the way back to the 1970s when another nascent technology—the Betamax video tape recorder—was making waves. Though the article does not specifically address 3-D printing in the surgical robotics context, the legal principles described therein are universally applicable. The article can be found here.
In January, I posted regarding the impact of the Florida Supreme Court’s decision in Aubin v. Union Carbide Corp., 177 So. 3d 489 (Fla. 2015). In that post I explained that even after Aubin, the consumer expectations test should not be applied in all design defect strict product liability cases because it is still up to the individual trial court judges to decide whether the consumer expectations and risk-utility tests should be given alternatively or together depending on the individual circumstances presented in each case. Some of the reasons for this conclusion included that the standard jury instructions remain unchanged; that numerous courts have ruled some products are too complex for the application of the consumer expectations test; that cases subject to the learned intermediary doctrine by definition involve a product too complex to permit the application of the consumer expectations test; and that the risk-utility test traces its roots to the Restatement (Second) of Torts, not the Restatement (Third) of Torts which was rejected in Aubin. Continue Reading
Not too long ago, I had the distinct pleasure of speaking at Shook Hardy & Bacon’s Update of the Law CLE conference in front of about 700 lawyers. Given the overlap in issues between emerging technologies like surgical robotics and 3D printing, I was asked to give a quick 15 minute presentation regarding 3D printing. In the video below you can watch that presentation. In it, I discussed the eight currently available 3D printing methods, how 3D printing is used, the numerous parties that may be implicated in a product liability lawsuit involving 3D printing, potential theories of liability against manufacturers who use 3D printing, and some possible available defenses. I concluded by offering some practical suggestions that manufacturers can implement to limit or eliminate liability in the event of litigation.
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
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
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