Lance Shea Email & Phone Number

I represent clients at the intersection of science and law. My clients are primarily in the drug, medical device and cosmetic industries. I help them get and keep their products on the market, and defend them in litigation. I also advise on advertising claims by applying my experience in the law and ability to understand clinical trials and other epidemiology studies. While my work is focused on keeping my clients out of court, the cases I litigate usually involve complex scientific evidence and multiple expert witnesses.I practice before the FDA, EPA and other federal and state regulatory agencies. Often, these matters involve cutting-edge arguments based on interpretation of scientific studies. I share my years of experience interpreting matters of law as they impact scientific advances at professional associations, universities and industry meetings.Speaking & Teaching:“Regulatory Science and the New FDA: Eight New Priorities That You Must Understand,” DRI Drug and Medical Device Conference, New York City, presenter (May 2013)“Postmarket Surveillance Strategies Across FDA,” 54th Annual Conference, Food & Drug Law Institute, Washington, DC, co-moderator (April 2011)“Navigating Expert Discovery,” For The Defense 14, co-author (November 2010)“Reviewing Clinical Trials and Observational Studies: A Practical Guide to Assessing Scientific Validity and Casual Leverage,” 1 Monograph Series 3, Food & Drug L. Inst., co-author (2009)“FDA and FTC Issue First Joint Warning Letter,” Fulbright Briefing, co-author (October 23, 2009)“Cause and Effect? Assessing Postmarketing Safety Studies as Evidence of Causation in Products Liability Cases,” 62 Food & Drug L.J. 445 (2007)My next course in scientific evidence will be offered Spring 2013, at the University of Maryland Francis King Carey School of Law.

Listed skills include Pharmaceutical Litigation, Medical Device Litigation, Fda Regulatory Matters, Epa Regulatory Matters, and 19 others.