Annual CLE: "Health Care and Market Forces: Current Issues", Tuesday, October 9, 2012 - Topics include Biosimilars; Preemption and Liability for Generic Pharmaceutical Manufacturers; Update on HIPAA/HITECH; One Year Retrospective on the America Invents Act; Electronic Discovery Policy Issues; and Indiana Legal Ethics Update. Receive 6.0 Hours of Indiana CLE credit, including 1.0 hour of Ethics
October 9, 2012
Continuing Legal Education, Annual CLE
Health Care and Market Forces: Current Issues
CLE: 6.0 Hours
Speaker: Experts from the public and private sectors, as well as academia
Location: Wynne Courtroom (Room 100), Inlow Hall, 530 W. New York Street, Indianapolis, IN
Contact: Shaun Dankoski at 317-278-4789 or email@example.com
Please join us for this year's Annual Continuing Legal Education Program: "Health Care and Market Forces: Current Issues" to be held on Tuesday, October 9, 2012 in the Wynne Courtroom of Inlow Hall.
6.0 Hours of Indiana CLE credit, including 1.0 hour of Ethics will be available with this program.
Cost to attend is $275.00.
PARKING: Please note this change in parking location: Parking is available for a nominal fee at the Campus Gateway Garage, located near the corner of Michigan and California Streets.
- Preemption and Liability for Generic Pharmaceutical Manufacturers
- Update on HIPAA/HITECH
- One Year Retrospective on the America Invents Act
- Electronic Discovery Policy Issues
- Indiana Legal Ethics Update
|8:15 a.m.-8: 45 a.m.||Registration|
|8:45 a.m.-9:00 a.m.||Welcome and Introductions|
|9:00 a.m.-10:00 a.m.||“Electromic Discovery - Current and Recurrent Issues” |
Hon. Matthew Kennelly, U.S. District Court, Northern District of Illinois
|10:00 a.m.-11:00 a.m.||“Is it game over for product liability suits against generic manufacturers? The Scope of Preemption in the Wake of the U.S. Supreme Court's decision in Mensing” |
Mary Larimore, Ice Miller LLP
|11:00 a.m.-11:15 a.m.||Break|
|11:15 a.m. -12:15 p.m.||"Update on Electronic Health Records: HIPAA and HITECH" |
Professor Sharona Hoffman, Case Western University
|12:15 p.m.-1:15 p.m.||Lunch (no speaker, boxed lunch provided)|
|1:15 p.m.-2:15 p.m.||“The America Invents Acts: Implementation Progress One Year After Enactment” |
Janet Gongola, ’03, U.S. Patent and Trademark Office
|2:15 p.m.-2:30 p.m.||Break|
|2:30 p.m.-3:30 p.m.||“Biosimilars: Recent Developments & Hot Issues” |
Erika Lietzan, Covington and Burling LLP
|3:30 p.m.-4:30 p.m.||Update of Indiana Lawyer Discipline Cases (1.0 hours of Indiana Ethics credit) |
G. Michael Witte, ’82, Indiana Disciplinary Commission
Janet Gongola, J.D.‘03 is the Patent Reform Coordinator at the U.S. Patent and Trademark Office (USPTO). In this capacity, she manages all aspects of the agency’s implementation of the America Invents Act. She has been an Associate Solicitor in the Office of the Solicitor at the USPTO where she provided legal advice to agency officials and defended decisions of the Board of Patent Appeals and Interferences and the Trademark Trial and Appeal Board before the U.S. Court of Appeals for the Federal Circuit as well as district courts across the country. Before joining the USPTO, Gongola served as a law clerk for Chief Judge Paul R. Michel at the Federal Circuit and for Chief Judge Sue L. Robinson in the U.S. District Court for the District of Delaware. She previously worked as a patent attorney, patent agent, and research chemist at Eli Lilly and Company. An officer of the Giles S. Rich American Inn of Court, she has served as an adjunct professor at the George Mason University School of Law and currently teaches at the George Washington University Law School. A summa cum laude graduate of IU McKinney School of Law, she received her B.S. degrees in Chemistry and Mathematics from Muskingum University.
Sharona Hoffman, J.D., LL.M., is the Edgar A. Hahn Professor of Law and a Professor of Bioethics at Case Western Reserve University. She is also the Co-Director of the law school’s Law-Medicine Center. She received her B.A. magna cum laude from Wellesley College, her J.D. cum laude from Harvard Law School, and an LL.M. in health law from the University of Houston. Professor Hoffman teaches Health Law courses, Employment Discrimination, and Civil Procedure. She has worked closely with the Centers for Disease Control and Prevention, the Institute of Medicine, the Agency for HealthCare Research & Quality, and other prestigious national organizations. She has lectured throughout the United States and internationally and has been widely quoted in the press, including in USA Today, The Los Angeles Times, and The New York Times. Professor Hoffman has published over fifty articles and book chapters, most of which focus on health law and civil rights law. Her current research focuses on the legal and ethical implications of health information technology.
Judge Matthew F. Kennelly was appointed to the United States District Court for the Northern District of Illinois by President Bill Clinton in 1999. Before his appointment, Judge Kennelly worked as an attorney in private practice in Chicago, representing individuals and corporations in complex civil cases and in criminal cases of all types, in both trial and appellate courts. He is a past recipient of the American Bar Association’s Pro Bono Publico award, the Public Interest Law Initiative citation for distinguished public service, and the Mexican-American Legal Defense and Education Fund’s Community / Public Service award. In 1993, the Chicago Chapter of the Federal Bar Association awarded him its Walter J. Cummings Award for excellence in advocacy. Since his appointment to the court, he has taught appellate advocacy at Northwestern University School of Law and has lectured extensively on a variety of subjects, including civil and criminal procedure, patent and trademark law, employment law, and ERISA law. From 2005 through 2012, he served on the Information Technology committee of the Judicial Conference of the United States. He also serves as a member of the Seventh Circuit Criminal Jury Instruction Committee and the Seventh Circuit Civil Jury Instruction Committee. He chaired the committee that drafted the Northern District of Illinois’ Local Patent Rules. In 2011, the Intellectual Property Law Association of Chicago awarded Judge Kennelly its Judicial Service Award. Judge Kennelly received a B.A. with highest honors from Notre Dame (1978) and a J.D. from Harvard Law School with high honors (1981).
Erika Lietzan, J.D. is a partner at Covington and Burling LLP in Washington, D.C. She specializes in US and ex-US regulation of drugs and biological products. Her areas of special focus at this time include biosimilars; the Hatch-Waxman amendments and BPCIA; data and market exclusivities; WHO initiatives relating to drugs and biologics; comparative effectiveness and health outcomes research; supply chain issues (e.g., counterfeiting, pedigrees, importation, and online pharmacy); drug safety (e.g., risk management and pharmacovigilance); and interactions with healthcare professionals (e.g., samples, grants, advertising and promotion, and PhRMA Code). She speaks and publishes regularly on these topics. For two years, Lietzan was Assistant General Counsel of PhRMA. She is past chair of the Biotechnology Committee of the American Bar Association, and she is currently a member of the FDLI Board of Directors and an elected member of the American Law Institute. She holds a B.A. from the University of North Carolina at Chapel Hill; M.A. from the University of California, Los Angeles; and J.D. from Duke University School of Law.
Mary Nold Larimore is a partner at Ice Miller LLP in Indianapolis. Her primary practice concentration is in litigation, focusing on product liability litigation, the defense of pharmaceutical and drug and device manufacturers, chemical companies, toxic tort litigation, commercial litigation, property damage litigation including the defense of mold claims alleging property damage and personal injury, and general liability litigation. Larimore has served as national, regional and local counsel in drug, device and chemical exposure litigation, as well as expert witness counsel. She regularly addresses scientific, epidemiologic and complex medical issues in multijurisdictional litigation. Larimore has been active in publishing and speaking on issues concerning product liability, legal issues affecting the liability of pharmaceutical and drug and device manufacturers, privacy, electronic discovery, medical malpractice and the Federal Rules of Evidence. She earned her B.A. from Indiana University and her J.D. from IU Maurer School of Law in Bloomington.
G. Michael Witte, ’82 is the executive secretary of the Indiana Disciplinary Commission. He was the first Asian American to serve as judge in Indiana. His 25 year judicial career included service as Judge Pro Tem of the Wayne Superior Court No. 1; Judge of the Dearborn Superior Court No. 1; and Judge of the Dearborn County Court. He received both his B.A. and J.D. degrees from IU, served as President of the Indiana University Robert H. McKinney School of Law’s Alumni Board in 2009, and was honored in 2008 by the IUAA as its Distinguished Asian Alumni. He is a graduate of the Indiana Judicial College, the Graduate Program for Indiana Judges, and a former member of the Indiana Commission on Courts. He served as chair of the ABA Judicial Division and chair of the ABA National Conference of Specialized Court Judges. Witte joined The National Judicial College faculty in 1994. In addition, he has served as faculty for programs presented by the American Bar Association, National Highway Traffic Safety Administration, the National Center for State Courts, the National Criminal Justice Association, the Indiana Judicial Center, and the Indiana Continuing Legal Education Forum. Witte’s teaching experience is primarily in legal ethics, impaired driving, and traffic court administration.
Moderator: Andrew R. Klein, J.D. is the Paul E. Beam Professor of Law at Indiana University Robert H. McKinney School of Law. He is also Chief of Staff, Office of the Chancellor and Associate Vice Chancellor for Academic Affairs for IUPUI. He joined the law school in 2000, after eight years on the faculty at Samford University’s Cumberland School of Law. Before entering the academy, Professor Klein practiced law with the Chicago firm of Sidley & Austin, specializing in products liability litigation involving pharmaceutical products. He earned his B.A. with distinction in journalism and economics from the University of Wisconsin and a J.D. with distinction from Emory University School of Law, where he studied as a Robert W. Woodruff Fellow in Law and was editor-in-chief of the Emory Law Journal. Following law school, Professor Klein served as a law clerk to Judge Joseph W. Hatchett of the U. S. Court of Appeals for the Eleventh Circuit. A member of the Illinois bar and the American Law Institute, Professor Klein also serves as Reporter for the U.S. Court of Appeals for the Seventh Circuit Civil Jury Instructions Committee. He is co-author of a casebook, Torts: Cases, Problems and Exercises (Lexis/Nexis 2nd ed. 2005). In addition to being an active scholar, Professor Klein is a dedicated classroom teacher who has won eight student teaching awards during his career. Professor Klein also is a national lecturer on tort law for BarBri Bar Review.