It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we see and touch and has served as a catalyst for much of our content. At the time of his retirement, George Butler, one of the founding members of Butler Snow, remarked that the Xerox machine had been the innovation with the most impact upon the practice of law in his time. Imagine how he might react today as we maneuver our way through social media, autonomous vehicles, 3-D printing, gene therapies, and even digital drugs. The prospect of litigation financing would have truly boggled his mind.
Reflection on the first ten years of Pro Te necessarily involves looking through the prism of our own experiences, both personally and professionally. As in the rest of the world, much has also changed at Butler Snow. Only a decade ago, our firm was less than 100 lawyers with three offices. Today, we stand at 350 lawyers in 24 offices in the United States and internationally. Our pharmaceutical, medical device, and healthcare practice has grown into a truly national practice with trials in more than 30 states, regulatory and compliance counseling, and business advice to pharmaceutical and medical device companies as well as to hospitals. We have been privileged to be involved in some of the most exciting and innovative developments affecting our clients this decade.
All of us working with Pro Te recall articles discussing new developments, which have become our “go-to’s” on the topics. We find those oft-referenced issues dog-eared, tabbed, and stacked on a corner of our desk, under excerpts from the CFR and alongside the Rules of Civil Procedure. We hope you have collected some of those. Other articles addressed more general topics that, once considered, have given us new tools to apply to the challenges we deal with every day. Our hope from the very first issue of Pro Te has been to give you, our clients, friends, and colleagues, articles and topics you find valuable and that provide solutions rather than simply discussions. We try with each issue to identify and explore a spectrum of topics relevant to your work in pharmaceuticals, medical devices, biologics, and health system and healthcare practices. It has been our pleasure to keep our ear to the proverbial ground, and we
thank you for the opportunity to serve you in this way.
When the journal’s ten-year anniversary came into focus, we pondered what to include in this special issue that you would find valuable. Should we do a retrospective? Should our ten-year issue be forward-looking? Should we wax eloquent on the practice of law and the unique opportunities and responsibilities that we, as lawyers in this field, encounter in the United States and abroad? At the end of the day, we decided it best to cover what birthed this journal and still drives it – content that offers solutions for you. Hence, Pro Te: Solutio. We settled on the importance of looking at FDA and regulatory topics that have been relevant for the past ten years and that remain relevant (in some cases even more so) today. See A Look Back at Ten Key FDA Initiatives over the Past Decade. We decided it only fitting to take a look back with a more nuanced approach by
focusing on what we know now that we wish we had known then. See What We Wish We Knew Ten Years Ago. Finally, we also thought it important to include a topic we believe will shape the future of our practice in pharma, device, and biologics. See Next Decade To-Do: Enforce Preemption for Class II Devices with Special Controls.
While we recognize our approach has not always been statute-, regulation-, or rule-specific – all of which are central to our practice – we also recognize that the value
of a bigger picture view – in law, in life, and in relationships – cannot be overstated. We hope you do, too. As we transition into a new decade of Pro Te, Charles and I believe it is time for our editorial board to take on the leadership role and overall management of Pro Te. We will still be here encouraging new topics and solutions for our clients, but we know our editorial board is more than prepared for the challenge ahead. We hope you enjoy this special edition and continue to enjoy Pro Te for years to come.
To download the full issue of Pro Te: Solutio, click here.