Sean Burke is partner and vice-chair of the products liability trial division at Duane Morris. He is in the firm’s Washington, DC office. Mr. Burke’s practice focuses on the representation of manufacturers of medical devices in products liability cases across the country, including in consolidated multi-plaintiff matters in both federal court and state courts. His experience includes defense of large total joint replacements (hips, knees, ankles, and shoulders) and resurfacings, tissue matrices and patches, fusion plates, and surgical instruments. He has a particular interest and focuses on additive manufacturing, consulting and advising clients on best practices in the early stages of development to reduce the risk of products liability exposure. He has tried medical device cases before juries in both state and federal courts while also handling numerous mediations. He works closely with scientific experts to advance causation and liability defenses in the areas of biomechanical engineering, toxicology, histology, epidemiology, orthopedic surgery, and FDA regulations. Sean will be speaking at the upcoming 3DHEALS webinar: Legal Landscape- Intellectual Properties and Product Liability.
Jenny: When was the first encounter you had with 3D printing? What was that experience like? What were you thinking at that moment?
Sean: Nearly a decade ago, I had dinner at a friend’s house and he had just bought a small 3D printer. He was running a print of a model Eiffel Tower. The print had been going for hours, and it was still working on the base. I remember thinking that it was a cool concept, but it had a long way to go before being practical.
Jenny: What inspired you to start your journey/company/career/research in 3D printing (bio-fabrication/bio-printing)?
Sean: As trial attorney, we work a lot with experts, and in the field of medical devices, we work very closely with engineers. At dinner with our primary engineering expert, he was telling me about his work with 3D printing medical devices, the benefits of it, and the potential issues. The development and potential of this innovation was exciting, but it also raised immediate questions in my mind regarding how the technology would fit in the current legal and regulatory landscape. I started doing some research and realized many of these issues were unaddressed by the regulations and case law, leaving companies in the difficult position of trying to mitigate risks associated with products liability, but without knowing the framework within which those risks will be evaluated.
Jenny: Who inspired you the most along this journey in 3D printing (bio-printing/bio-fabrication)? This can be a mentor, a patient, a celebrity, anyone basically. You can name more than one as well.
Sean: Engineers at Exponent first peaked my interest in this area and it has only been increased by the passion the 3D printing medical device industry has for this technology. From startup company founders, to 3DHeals and the team at 3Dprint.com, there is an excitement and energy in this niche industry fueled by the potential opportunities 3D printing technology can provide.
Jenny: What motivates you the most for your work?
Sean: Attending industry conferences, I have seen the case studies presented by various companies about some of the tremendous results achieved for patients using the benefits of 3D printing, especially in the area of customized devices for facial reconstruction. These companies are doing truly amazing things and as part of the legal community, I am motivated by the thought that I can help protect these companies from future risks, to allow them to continue to help the public.
Jenny: What is/are the biggest obstacle(s) in your line of work? If you have conquered them, what were your solutions?
Sean: From my vantage point, as a products liability attorney, the biggest obstacle is predicting the unknown. Many of the well established tenets of products liability law are turned upside down by the 3D printing process. For example—who can be deemed a manufacturer subject to strict liability, especially in a point of case setting? The CAD file designer, the printer manufacturer, or whoever actually prints the device? Can the software use to print the device be considered a product? What unique exposure do material providers have that they may not otherwise have in traditional manufacturing chains? All of these questions are still developing answers. Legal challenges arise where, as is the case here, innovation is moving faster than the law.
Although I recognize many startup companies are focused on bringing their products to market in the most efficient manner possible, there are some simple steps, that can be taken in the development and regulatory clearance stages which can better protect a company from future risks of products liability exposure. I look forward to discussing some of these issues at the upcoming webinar.