Greenberg Traurig is one of the largest law practices in the United States, with 2,100 attorneys serving clients in 41 offices in the U.S., Europe, Latin America, the Middle East and Asia.
Medical Design & Outsourcing recently sought insights from some of the top lawyers at GT who are involved in medical device products liability and intellectual property: Ginger Pigott, Michael R. Goodman and patent attorney Roman Fayerberg.
MDO: Medtech companies are increasingly packaging sensors, software and other digital features into their devices. How is going digital shifting the way device companies protect their intellectual property? What kind of new liability challenges is it creating?
Pigott/Goodman: The inclusion of software, digital features, data sharing and remote access are all at the forefront of medical device technology and associated therapies. They also introduce new liabilities. For example, is there a possibility that the software will depart from its intended use? Can an implanted sensor-transmitter withstand the body’s own defenses? Are these products secure from evolving outside threats and to what extent might the software developer or device manufacturer be liable?
We are also seeing non-traditional companies competing in this space with devices that blend the practical with the medical. More and more apps and fitness devices incorporate health data or tracking. And, with the advent of 3D printing, tech companies are entering into the medical device space. But if there is a software error when designing a product from a 3D printer, for determining liability, it is unclear whether the software is also the product or just the medical device. It may simply depend on whether the state considers a product “tangible.” These are a few examples that may challenge some of the traditional legal defenses that have protected prescription medical devices.
Fayerberg: With respect to the intellectual property protection, medtech companies will need to be more strategic in the way they protect their intellectual property. Protection of the digital features introduces additional considerations that do not arise when protecting more traditional medical devices. In particular, some digital features, mobile apps or software may not be eligible for patent protection. Accordingly, medtech companies will need to carefully consider which digital features of their devices can be protected with patents, and which other options are available to them to protect their intellectual property, including trade secrets. Medtech companies will also need to ensure that their patent counsel are experienced in both traditional medical devices and software patents.
MDO: Robotic surgery appears to be the hot new area in medtech, with almost every major medical device company seeking to do something in the field. What is your perspective on the trend?
Pigott/Goodman: Robotic surgery and the use of such systems continues to develop and the trend is on the upswing. Such innovation has not and will not eliminate adverse outcomes, however. Technology and its assistance in performing surgery — as well as its ability to document the procedure and preserve such evidence means that we have more information when evaluating “what went wrong.” The question becomes, though, when the something does not go as expected or desired, who is responsible? Just a few years ago, it was a doctor and a scalpel (or other tools). Now, it is a doctor, his or her tools and a robotic tool that has both hardware and software (not to mention maintenance requirements). What has not yet changed is that the doctor still controls the surgery. Though the technology is improving, it is becoming more complicated with more peripherals that can go wrong and frankly, the investigation on an injury is much more nuanced and complicated. That said, robotic surgery gives surgeons a significant advantage in both accuracy and, in many cases, speed of surgery.
Fayerberg: We are seeing an increase in the number of issued patents and filed applications for robotic surgery. The patent claims can be directed to the overall system or to the individual tools. On the other hand, as some of the earlier, broader patents are expiring, we expect to see new robotic companies emerging. In addition to the surgical robots, we are seeing an increase in the patenting activity related to the robotic principles for use in assistive and therapy devices, such as exosuits for stroke victims.
MDO: When you look at the way things were five years ago and the way they are now, what’s the major difference — and what is your top piece of advice based on the difference?
Pigott: Five years in medical device innovation has become a lifetime as such new technologies and uses are coming quicker than ever. While the increasing pace of development itself is not particularly new, the speed — combined with types of competitors in this space, scope and access by larger areas of the world, and the expectations for what technology can do — have all made things more complicated than ever in terms of how to prepare for claims. My advice from the litigation side is that success will always bring litigation and success followed by any reasonable challenges — e.g. field actions, recalls, newly discovered potential adverse effects — is going to bring litigation even faster. Keeping that in mind, careful consideration of pathway to market choices, such as regulatory clearance versus approval, characterization and classification of the device, and even simple record keeping and communication can all go into protection or greater risk. Risk may not be able to be eliminated, but it can be significantly reduced and mitigated by smart and organized companies with an eye toward the day that not only the FDA (or other country equivalent) shows up for an audit, but the day when the inevitable adverse event turns into litigation.
Fayerberg: With respect to the intellectual property, as the competition increases, it is more important than ever to have a cohesive patent strategy. An effective, strategic patent portfolio is designed with both offensive and defensive considerations, and should include patents with varying scope of protection.
Ginger Pigott (Los Angeles) is vice chair of Greenberg Traurig’s Pharmaceutical, Medical Device & Health Care Litigation Practice and focuses her practice on products liability litigation with an emphasis on the defense of complex medical device and pharmaceutical products.
Michael R. Goodman (Denver) is a Greenberg Traurig attorney and registered patent agent advising clients in the medical device, pharmaceutical, biotechnology, food and dietary supplement industries on FDA regulatory compliance and products liability matters.
Roman Fayerberg (Boston) is a registered patent attorney at Greenberg Traurig. He focuses his practice on the development and management of strategic patent portfolios and counseling clients on patent issues.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.