(Washington, D.C./March 12, 2009) Baker, Donelson, Bearman, Caldwell & Berkowitz, PC today announced the addition of two members to the Firm's D.C. health care team. Judith K. Meritz joins as an attorney with FDA experience and Jennifer M. Summa, joins the Health Care Policy Group as a senior public policy advisor. The health care team consists of policy strategists and attorneys with decades of legal, legislative and industry experience, including former Representative Nancy Johnson (R-CT) who chaired the House Ways and Means Health subcommittee, as well as White House and former senior HHS advisors. The Firm was ranked as one of the five largest health care law firms in the U.S. and by Best Lawyers in America® as second in the nation in the area of health care law.
Ms. Meritz will focus her practice on FDA issues including counseling, compliance and enforcement in the areas of pharmaceuticals, medical devices, biologics and dietary supplements. Prior to joining Baker Donelson, Ms. Meritz worked as a partner at Blank Rome LLP, where she specialized in FDA compliance counseling in the areas of drugs, devices and life sciences. In addition to her work with government agencies, Ms. Meritz led drug and device recalls and handled due diligence matters for new acquisitions and business ventures.
Before her work in the private sector, Ms. Meritz worked as Assistant General Counsel for the American Red Cross (ARC). In this position, Ms. Meritz was responsible for regulatory compliance and served as Chief Counsel to the Biomedical Services group. Ms. Meritz also served as Vice President of Regulatory Affairs at E-Z-EM, Inc., a leading manufacturer of drugs, devices and diagnostics. Her other past positions include Regulatory Affairs/Regulatory Counsel for Henry Schein Inc and Assistant Regional Counsel for the U.S. Environmental Protection Agency, Region II. Ms. Meritz writes and lectures extensively on good manufacturing practices and facilitating successful FDA interactions and inspections.
Ms. Meritz is a graduate of American University School of Public Affairs, received her J.D. from Pace University Law School and dual masters degrees from the University of Michigan. She serves as Chair for the Food and Drug Law Institute’s Law Journal. Ms. Meritz is also a member of the BNA Advisory Board for the Medical Devices, Law and Industry Report and presently serves on the American University Alumni Board. She formerly held the position of Alumni Chapter President of the School of Public Affairs at American University. She is admitted to practice law in Washington, DC and New York.
Jennifer Summa will focus on assisting clients in navigating the intricacies of the Department of Health and Human Services and the Center for Medicare and Medicaid Services. Prior to joining Baker Donelson, Ms. Summa was a Senior Advisor in the Health Care and Life Sciences Practice in the Washington, DC office of Epstein, Becker & Green (EBG). She focused primarily on Medicare and Medicaid regulatory issues; third party coding, coverage and payment. Before joining EBG in December 2007, Ms. Summa spent four years as a senior career employee working for the Center for Medicare and Medicaid Services within the Department of Health and Human Services. CMS has a budget of $600 billion and is the largest spending agency in the government.
Ms. Summa began her career with the government at the Departmental Appeals Board in 2003, before signing on as former CMS Acting Administrator Leslie Norwalk's Special Assistant for two years. Ms. Summa was detailed by CMS to the Senate Finance Committee Oversight and Investigations in 2006, before returning to the CMS Office of Policy as a Senior Advisor to Ms. Norwalk and former Secretary of Health and Human Services Mike Leavitt on health care rebuilding in New Orleans.
Prior to her government service, Ms. Summa spent nearly four years working as a lobbyist representing clients in the healthcare, telecommunications and defense industries on a wide array of FDA, tax and appropriation issues.
Ms. Summa is a graduate of Wellesley College and received her J.D. from Georgia State University College of Law. She also earned an M.P.H from Drexel University. Ms. Summa is currently a member of the Georgia and New Mexico bars, and a member of the American Public Health Association and the New Mexico Hispanic Bar Association.
“We are very proud of the talent the Firm has attracted over the years, particularly in the area of health care,” said Keith Kennedy, chair of the Firm's Federal Public Policy Group and the Managing Director of the Washington, D.C. office. “Health care is one of the most important items on the national agenda – the ability to navigate the labyrinth bureaucracies of the related agencies is a crucial asset to have at this time. Jennifer’s and Judith’s respective experience working with the FDA and at the Center for Medicare and Medicaid Services will be extremely valuable to our clients.”