Brian Anderson is a partner in O’Melveny & Myers’ Washington, D.C., office. Mr. Anderson focuses on the defense of all forms of aggregated litigation, including class actions, mass torts, multidistrict proceedings, state attorney general lawsuits and investigations, and mass-joinder actions. He has led the defense of complex aggregated actions against product manufacturers and service providers in many industries, including motor vehicles, pharmaceuticals, technology, and insurance. His practice covers the law of product liability, negligence, common law and statutory fraud, express and implied warranty, RICO, environmental regulation, insurance regulation, and employee benefits. Mr. Anderson is an adjunct professor of law at Georgetown University Law Center, and he has published many articles on complex litigation, submitted amicus briefs in landmark appellate cases, spoken at legal conferences, been quoted in the media, and testified before the federal Judicial Conference in support of amendments to the class action rules. Mr. Anderson is a member of the executive committee of the board of trustees of Ford’s Theatre in Washington, D.C. He also serves on a pro bono basis as legal counsel to the D.C. Public Charter School Board.
James Beck is of counsel to Dechert LLP. Mr. Beck is a member of the Mass Tort and Product Liability Litigation Group at Dechert and specializes in the defense of complex product liability cases, primarily involving prescription medical products. He is an experienced appellate practitioner in the courts of Pennsylvania and elsewhere. Between 1993 and 2001, Mr. Beck was part of the core national counsel defense team in the Orthopedic Bone Screw multidistrict litigation, representing the largest manufacturer of the product. In connection with this representation, Mr. Beck wrote a law review article, "FDA, Off Label Use and Informed Consent: Debunking Myths and Misconceptions," published in the Food and Drug Law Journal in 1998, that has become a seminal work in the field. This article has been cited by several appellate courts, including the U.S. Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, concerning the off-label use of prescription medical products. Mr. Beck has also filed amicus briefs about off-label issues, most recently for the Washington Legal Foundation in the Seventh Circuit United States v. Caputp case. Mr. Beck is the lead author of Drug and Medical Device Product Liability Deskbook (Law Journal Press, 2004) and editor of the ABA Mass Tort Litigation Newsletter. He is a member of the Product Liability Advisory Council and the American Law Institute.
Jeffery S. Bucholtz has been the principal deputy assistant attorney general in the Civil Division of the U.S. Department of Justice since April 2006 and has been the acting assistant attorney general for the division since November 2007. Mr. Bucholtz joined the department in September 2002 as the deputy assistant attorney general responsible for the Civil Division’s Torts Branch, and he also assumed responsibility for the Office of Consumer Litigation in February 2004. Before joining the department, Mr. Bucholtz was in private practice at King & Spalding LLP in Washington, D.C., where he focused on appellate litigation, and at Williams & Connolly LLP. Mr. Bucholtz clerked for the Honorable Stephen V. Wilson, U.S. district judge for the Central District of California, and then for the Honorable Samuel A. Alito Jr., then–U.S. circuit judge for the Third Circuit.
John E. Calfee is a resident scholar at AEI. He previously worked on the economics of consumer protection—including advertising and marketing, the tort liability system, tobacco, and other topics—at the Bureau of Economics at the Federal Trade Commission. He has taught marketing and consumer behavior at the business schools of the University of Maryland at College Park and Boston University and spent a year as a visiting senior fellow at the Brookings Institution. Mr. Calfee’s academic articles and opinion pieces cover a variety of topics, including tort liability, advertising and information, Food and Drug Administration (FDA) regulation, and the pharmaceutical market. His op-eds have run in the Wall Street Journal, the Philadelphia Inquirer, the Los Angeles Times, and numerous other newspapers and magazines. His recent scholarly publications have appeared in Clinical Pharmacology and Therapeutics, Health Affairs, and the Supreme Court Economic Review. He has published three short books: Fear of Persuasion: A New Perspective on Advertising and Regulation (AEI Press, 1997); Prices, Markets, and the Pharmaceutical Revolution (AEI Press, 2000); and Biotechnology and the Patent System: Balancing Innovation and Property Rights, with Claude Barfield (AEI Press, 2007). He has also testified before Congress and federal agencies on various topics, including alcohol advertising; biodefense vaccine research; international drug prices; the Vioxx episode; and, most recently, FDA oversight of drug safety.
Theodore H. Frank is a resident fellow at AEI and director of the AEI Legal Center for the Public Interest. He manages the Institute’s research in legal studies and specializes in product liability, class actions, and civil procedure. Before joining AEI, Mr. Frank was a litigator from 1995 to 2005 and clerked for the Honorable Frank H. Easterbrook on the Seventh Circuit Court of Appeals. Mr. Frank has written for law reviews, the Wall Street Journal, the Washington Post, and National Review Online and has testified before Congress multiple times on legal issues. He writes for the award-winning legal blogs PointOfLaw.com and Overlawyered, and the Wall Street Journal has called him a "leading tort-reform advocate."
Scott Gottlieb, M.D., is a practicing physician and a resident fellow at AEI. A leading expert in health care policy, Dr. Gottlieb’s work focuses on providing insights into the economic, regulatory, and technological forces driving the transformation of health care today. From 2005 to 2007, Dr. Gottlieb served as Food and Drug Administration (FDA) deputy commissioner and, from 2003 to 2004, as a senior adviser to then–FDA commissioner Mark McClellan and as the FDA’s director of medical policy development. A recipient of numerous medical association awards, Dr. Gottlieb is the author of more than three hundred articles that have appeared in leading medical journals, as well as the Wall Street Journal, the New York Times, USA Today, and Forbes. Dr. Gottlieb has held editorial positions on the British Medical Journal and the Journal of the American Medical Association and appears regularly as a guest commentator on CNBC. Previously, Dr. Gottlieb worked as a health care analyst for the investment bank Alex Brown & Sons and authored the Forbes-Gottlieb Medical Technology Letter and the Gilder Biotech Report. Dr. Gottlieb has testified as an expert witness on health and regulatory matters before the U.S. Senate and House of Representatives and members of the Japanese Diet.
Michael S. Greve is the John G. Searle Scholar at AEI. His research and writing cover constitutional law, federalism, and business regulation. Mr. Greve cofounded and, from 1989 to 2000, directed the Center for Individual Rights, a public interest law firm that served as counsel in many precedent-setting constitutional cases, including United States v. Morrison and Rosenberger v. University of Virginia. He has written widely on constitutional and administrative law, federalism, environmental policy, and civil rights.
Robert B. Helms is a resident scholar in health policy studies at AEI. He has written and lectured extensively on health policy, health economics, and the economics of the pharmaceutical industry. Mr. Helms currently participates in the Consensus Group, an informal task force that is developing market-oriented health reform concepts. He also serves on the National Advisory Council for Healthcare Research and Quality of the Agency for Healthcare Research and Quality. Mr. Helms is the editor of several AEI books on health policy, including American Health Policy: Critical Issues for Reform (AEI Press, 1993), Health Policy Reform: Competition and Controls (AEI Press, 1993), Competitive Strategies in the Pharmaceutical Industry (AEI Press, 1996), and Medicare in the 21st Century: Seeking Fair and Efficient Reform (AEI Press, 1999). He has also written on the history of Medicare, the tax treatment of health insurance, and international comparisons of health systems. From 1981 to 1989, he served as assistant secretary for planning and evaluation and deputy assistant secretary for health policy in the Department of Health and Human Services.
Mark Herrmann is a partner in the Chicago office of Jones Day. He has defended multidistrict litigation and hundreds of class actions filed throughout the federal system and in most of the state court systems. Mr. Herrmann is the author of two books, Statewide Coordinated Proceedings: State Court Analogues to the Federal MDL Process (Thomson West, 2d rev, 2004) and The Curmudgeon’s Guide to Practicing Law (ABA Publishing, 2006) and more than fifty articles on legal topics. Mr. Herrmann hosts the Drug and Device Law Blog, the most widely read product liability blog. From 1997 to 2007, he taught complex litigation as an adjunct professor of law at Case Western Reserve University School of Law. Before joining Jones Day, Mr. Herrmann clerked for Judge Dorothy W. Nelson on the Ninth Circuit Court of Appeals.
Margaret Johns teaches torts, constitutional law, and civil procedure at the University of California Davis School of Law. She is the author of four books and numerous articles on civil rights and tort law. She has received awards for teaching, public service, and pro bono activities. She is currently the chair of the Advisory Committee on Rules of Practice for the U.S. Ninth Circuit Court of Appeals. Her recent article, "Informed Consent: Requiring Doctors to Disclose Off-Label Prescriptions and Conflicts of Interest," appears in 58 Hastings L. J. 967 (2007).
Michael A. Krauss teaches torts, legal ethics, and jurisprudence at George Mason University School of Law and has a strong interest in national security issues. Before coming to George Mason in 1987, Mr. Krauss taught at the law schools of Seattle University, the University of Toronto, and the Université de Sherbrooke. In 1981, he was Columbia University’s law and economics fellow. Mr. Krauss practiced law for Quebec City’s largest law firm and served on Quebec’s Human Rights Commission for five years. A Salvatori Fellow of the Heritage Foundation and an academic fellow of the Foundation for the Defense of Democracies, Mr. Krauss sits on the advisory boards of several think tanks. He served as president of the Virginia Association of Scholars and on the board of governors of the education section of the Virginia State Bar and is currently a member of the board of governors of the National Association of Scholars. Mr. Krauss is the coauthor of Legal Ethics in a Nutshell (Thomson West, 2006) and is under contract with Thomson West to produce a book on product liability law in late 2008.
J. Leonard Lichtenfeld, M.D., is the deputy chief medical officer for the American Cancer Society. He is responsible for directing the society’s Cancer Control Science Department. Dr. Lichtenfeld is also recognized as a resource both within and outside the society for his expertise in oncology and medical affairs. He serves as a liaison for the society with many professional and public organizations and is a frequent spokesperson on behalf of the society on a variety of cancer related subjects. A board certified medical oncologist and internist who practiced for over nineteen years, Dr. Lichtenfeld has long been active in medical affairs on a local, state, and national level, and he has a long-standing interest in legislative and regulatory issues. He is a member of the Relative Value Update Committee of the American Medical Association, which works with the Centers for Medicare and Medicaid Services (CMS) to update the Medicare physician fee schedule, and also a member of CMS’s Medicare Evidence Development and Coverage Advisory Committee. Dr. Lichtenfeld has received several awards in recognition of his efforts on behalf of his colleagues and his professional activities. He has been designated a Master of the American College of Physicians in acknowledgement of his contributions to internal medicine.
John E. Osborn is a visiting research fellow with the Centre for Socio-Legal Studies at the University of Oxford, where he is a senior member of Wadham College. He served for ten years as executive vice president and general counsel with Cephalon, Inc., a Fortune 1000 biopharmaceutical company, where he was responsible for managing all legal, intellectual property, quality assurance, compliance, government, and public affairs matters. Prior to that, he was vice president and associate general counsel with the DuPont Merck Pharmaceutical Company. Mr. Osborn is a founding member of the board of directors of Incept BioSystems, Inc., a privately held biomedical device company based in Ann Arbor, Mich.; an adviser on life sciences regulatory and compliance matters to the international consulting firm McKinsey & Company; and a member of U.S. Advisory Commission on Public Diplomacy.
Richard Samp is chief counsel of the Washington Legal Foundation (WLF), a nonprofit public interest law firm located in Washington, D.C. WLF litigates in support of individual rights and the free-enterprise system and against excessive government regulation. Mr. Samp served as lead counsel in WLF v. Friedman, a federal court decision striking down Food and Drug Administration restrictions on the dissemination of peer-reviewed medical journal articles that contain information about off-label uses of approved drugs. Mr. Samp regularly litigates in federal court in support of broad First Amendment protection for commercial speech rights. Before joining WLF in 1989, Mr. Samp was a litigator at the Washington, D.C., law firm of Shaw Pittman.
D. Kyle Sampson is a partner in the Washington, D.C., office of Hunton & Williams, where he focuses on Food and Drug Administration (FDA) regulatory and enforcement issues. From 2003 to 2007, Mr. Sampson served as counselor and chief of staff to two attorneys general at the U.S. Department of Justice (DOJ). In these senior advisory roles, he provided advice on legal and policy issues, coordinated DOJ positions in criminal prosecutions and civil litigation, and formulated and implemented policy initiatives and legislative proposals. While at DOJ, Mr. Sampson was appointed a special assistant U.S. attorney in the Eastern District of Virginia and conducted trial and appellate litigation. In 2005, Mr. Sampson received the attorney general’s award for outstanding service. Previously, Mr. Sampson served as associate counsel to the president and as counsel to the U.S. Senate Judiciary Committee. Mr. Sampson is the author of numerous articles that have appeared in publications such as Variety, the Wall Street Journal, the Salt Lake Tribune, and The University of Chicago Law Review. His most recent article, "Labeling Changes and FDA’s Oversight of Drug Safety," appeared in HealthLaw360. Mr. Sampson clerked for the Honorable Karen J. Williams on the U.S. Fourth Circuit Court of Appeals.
George Terwilliger is a senior partner in the Washington, D.C., office of White & Case LLP. Mr. Terwilliger’s clients have included some of the world’s largest companies and most prominent individuals. He has represented energy, telecommunication, and industrial companies in government investigations and in civil and criminal litigation. Mr. Terwilliger has conducted and supervised corporate internal investigations, legal compliance reviews, and companywide legal risk management reviews around the globe. He has represented prominent academic medical centers and other entities in connection with government health care fraud investigations. Mr. Terwilliger served as a presidential appointee in two administrations, first as the U.S. attorney for the District of Vermont under President Ronald Reagan and then as deputy attorney general under President George H. W. Bush. He also served briefly as acting attorney general of the United States, capping a fifteen-year public service career. Mr. Terwilliger has ten years’ of experience as a front-line federal prosecutor conducting investigations, trials, and appellate proceedings. In private practice, Mr. Terwilliger continues to be involved in matters of public interest. He has served as counsel to a U.S. Senate investigation, outside general counsel to federal commissions, and confidant and counselor to elected and appointed officials. Mr. Terwilliger was also a leader of President George W. Bush’s legal team during the Florida election recount.
Daniel Troy is a partner in the Washington, D.C., office of Sidley Austin LLP, where he is a member of the Life Sciences Practice and the Appellate Litigation Group. Mr. Troy is the former chief counsel of the Food and Drug Administration (FDA). In addition to providing strategic counseling on FDA-related matters, Mr. Troy practices administrative and constitutional law and litigation, with particular focus on the industries regulated by the FDA. Mr. Troy regularly argues before federal and state courts of appeal and has appeared before the U.S. Supreme Court. Last year, he was chair of the American Bar Association’s Section of Administrative Law and Regulatory Practice. He served in the Office of Legal Counsel of the U.S. Department of Justice as an attorney-adviser. From 1983 to 1984, he clerked for D.C. circuit judge Robert Bork. Mr. Troy is the author of Retroactive Legislation (AEI Press, 1998) and was an associate scholar at AEI from 1998 to 2000. He has also been published in Commentary, the Wall Street Journal, The Weekly Standard, the Washington Times, National Review, The American Spectator, Legal Times, National Law Journal, the Journal of Law and Politics, Administrative Law Review, and Policy Review, among others.