The FDA’s Latest Warning: A Good Reminder Regarding the Litigation Risks of Off-Label Use

Last week, the FDA issued a warning against the use of robotic surgery for mastectomy and other cancer-related procedures. The warning stated, in relevant part, “To date, the FDA has not granted marketing authorization for any robotically-assisted surgical device for use in the United States for the prevention or treatment of cancer, including breast cancer.” The warning went on to say, “Be aware that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established.” This action came after the Agency reviewed certain literature suggesting that robotically assisted devices were being used “off-label” in cancer treatment. Incidents like this raise a very important question: How can a company avoid or minimize liability in the event of off-label use? Continue Reading

The Healing Touch: Haptic Feedback and the State-of-the-Art Defense

By Mihai Vrasmasu on February 20, 2019 Posted in Litigation, Surgical Robot

As more and more surgical robots make their way into operating rooms, companies are learning valuable lessons about how their devices function in the real world. Though many existing design features are proving highly effective, physician response suggests that current systems should evolve to include additional capabilities, like “haptic feedback.” While discussing what it’s like to perform surgery without it, a UCLA associate professor of electrical engineering recently explained, “You can see what you’re doing, but imagine trying to tie your shoes without having a sense of touch.” Continue Reading

Emerging Trends in Surgical Robotics Product Liability Litigation

By Mihai Vrasmasu on January 14, 2019 Posted in Litigation, Surgical Robot, Training

Over the last decade, robotics have revolutionized healthcare. Surgical robots are rapidly making their way into many of our nation’s operating rooms, and are being used in a wide variety of surgeries ranging from gynecological to ocular procedures. Their popularity stems not only from their relative ease of use, but also from their potential for improved patient outcomes and decreased recovery time.

As with any device or product, however, surgical robots and the companies that make them have not been immune from product liability lawsuits. Continue Reading

Can Robot-Assisted Surgery Be a Pain?

By Mihai Vrasmasu on June 7, 2017 Posted in Industry Insights, Litigation, Studies, Surgical Robot

Recently, my colleague Amy Foust made some really good points about a subject that is rarely discussed. Over the years, a number of patients have claimed that they were injured by surgical robots defective by design or manufacture. A recent study from Johns Hopkins University may now allow some to argue that surgical robots are also injuring surgeons. Continue Reading

Lessons Learned From the Intuitive Surgical Lawsuits: Physician Learning Curves

By Mihai Vrasmasu on February 28, 2017 Posted in Industry Insights, Litigation, Surgical Robot, Training

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

Lessons Learned From the Intuitive Surgical Lawsuits: The Benefits of Partnering With Independent Educational Firms

By Mihai Vrasmasu on January 30, 2017 Posted in Industry Insights, Litigation, Surgical Robot, Training

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

Shielding Intellectual Property from 3-D Printing’s Paradigm Shift

By Mihai Vrasmasu on December 22, 2016 Posted in 3-D Printing, Litigation

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.

Aubin v. Union Carbide—A Year Later

By Mihai Vrasmasu on October 19, 2016 Posted in Litigation

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

The 3D Printing Revolution: Everything at the Touch of a Button

By Mihai Vrasmasu on August 30, 2016 Posted in 3-D Printing, Litigation

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.

The Do-It-Yourself Surgery Genie is About to Escape the Bottle

By Mihai Vrasmasu on July 29, 2016 Posted in 3-D Printing, Surgical Robot

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