Robert Klepinski is an Officer with Fredrikson & Byron and practices in the Food, Drug & Medical Device Regulation, Health Care Fraud & Compliance and Intellectual Property Groups. Bob is also recognized as one of the leading FDA compliance attorneys. He counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA policy.
Bob retired from Medtronic, Inc., the world’s leading medical technology company. He served as general counsel for several of the Medtronic businesses, including Cardiac Rhythm Technology and Cardiac Surgery. While at Medtronic, he set the legal strategy for FDA compliance, including advertising and promotion, quality systems, regulatory and clinical.
Bob frequently speaks at both local and national trade associations on FDA policy. He has been an adjunct professor at the University of Minnesota Law School and a guest lecturer at other law schools. He is currently an adjunct professor at St. Thomas University in the Masters in Regulatory program at its Graduate School of Engineering and its mini MBA program.
Kai Peters is a partner with Gordon & Rees specializing in acting as outside general counsel for businesses on a broad range of corporate, commercial and litigation matters, and in representing businesses in simple and complex litigation.
Kai has significant experience in litigation, including product liability, mass torts, class actions, breach of contract, and business disputes. He has a particular emphasis in complex commercial litigation representing pharmaceutical, medical device, and other FDA-regulated companies, solar companies, and hi-tech and new media companies. Kai acts as national and local litigation counsel for companies of all sizes in state and federal courts, including in MDL’s and in coordinated proceedings. He has recovered significant sums in breach of contract matters as well. He also advises corporate clients in the area of avoidance of potential liability and litigation, from training and organization of sales representatives to the form and content of internal and external documents.
Kai has extensive experience in all phases of litigation, including the initial phases of litigation; development and preparation of witnesses for testimony; depositions of experts and company witnesses of all backgrounds (including special emphasis on working with sales representatives, regulatory employees, and company executives); analysis and development of defenses, including those based on medical and scientific causation issues, labeling, and preemption; motion practice; written discovery; major document organization and review (including e-discovery); summary judgment motions; alternative dispute resolution including mediation; evaluation of cases with experts; and the trial phase.
As outside general counsel, Kai advises clients of all sizes in a variety of business matters.
Additional speakers to be announced soon!