Consulting
-Drug Product Franchise Protection, including ANDA trials and international counterparts, landmark multiple first filer ANDA litigation settlements & Citizen Petitions (my efforts and ideas have helped to preserve significant revenue for my employers from threatened infringing or otherwise improper generic applications/products) -Innovative Lifecycle Management Theories -Successful Defense of Products Liability Matters, Shareholder, Contract & Employment Litigation, including: + Litigation Management + Landmark Federal Pre-emption Ruling in PL Matter + Succesful Summary Process in PL, Shareholder & Employment/Whisteblower Matters +Successful EEOC practice -Management of Regulatory & Governmental Issues, including: +Citizen Petitions +REMS Programs +Novel Pediatric Exclusivity Extension +GMP/GLC Issues +FTC Decision & Order Management +Goverment Promotion Inquiries Specialties: Litigation, including ANDA, IP, Anti-Trust, Products Liability, Contract and Employment Law; Employment Counseling; Regulatory & Compliance Interface