James P. Ellison
Consumer Product Safety Commission
J.D., Order of the Coif, University of Virginia School of Law
A.B., magna cum laude, Woodrow Wilson School of Public & International Affairs, Princeton University
District of Columbia
U.S. District Court District of Columbia
U.S. District Court District of Maryland
U.S. District Court Eastern District of Wisconsin
U.S. Court of Federal Claims
U.S. Court of Appeals, District of Columbia Circuit
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J.P. Ellison represents clients in enforcement matters, particularly civil, administrative, and criminal cases. He also advises clients on government investigations and compliance matters. Mr. Ellison regularly represents clients in state and federal courts throughout the country. His clients include a wide range of companies and individuals regulated by FDA, FTC, DEA, and the CPSC.
Mr. Ellison's trial experience encompasses litigation on behalf of both the government and industry. He has a keen sense of the government's priorities in FDA, FTC, DEA, CPSC, and state attorney general enforcement matters. This insight enables Mr. Ellison to take a practical approach in advising clients of their options and how to achieve the best result.
Before joining the firm in 2007, Mr. Ellison was a trial attorney with the U.S. Department of Justice's Office of Consumer Litigation (now called the Consumer Protection Branch). In this capacity, he handled litigation matters involving FDA, FTC, and the CPSC. In addition to working as a federal prosecutor, Mr. Ellison was the Chief Compliance Officer and Regulatory Counsel for a D.C. government agency. Mr. Ellison served as a law clerk for the Honorable Diana Gribbon Motz of the U.S. Court of Appeals for the Fourth Circuit.
• Lead counsel for several drug manufacturers in connection with Medicaid drug pricing lawsuits brought by various state attorneys general.
• Lead counsel for several drug manufacturers in Federal False Claims Act suit.
• Prosecuted and defended Lanham Act cases as lead counsel.
• Lead counsel in law suits under the Administrative Procedures Act against federal government agencies, including FDA and DEA.
• Helps clients resolve matters on favorable terms short of litigation through consent decrees, civil settlements, and other negotiated resolutions.
• Advises clients on responses to pre-litigation enforcement actions by the government such as FDA warning letters, state attorney general informal inquiries, civil investigation demands, and administrative and grand jury subpoenas.
Articles / Publications
• A Warning Letter on FDA's Expansive Interpretation of Its Facilities - Inspection Authority,
March 13, 2015
• The Curious Case of the Prosecution of Lawyer Paul Kellogg,
• Hyman, Phelps & McNamara Issues Analysis Discussing the Implications of the Supreme Court's Wyeth v. Levine Decision,
March 16, 2009
• ACI: National Forum on Pharmaceutical Pricing Litigation, Bolstering Trial Strategy in Litigation over AMP Calculations to Mitigate Exposure, October 2 - 3, 2012
• FDLI Conference on Enforcement and Litigation, Enforcement in a Post-Wyeth, New Administration World, October 13 - 14, 2009
see more blog entries
• Drug Manufacturers Shed No Tears Over Ruling that State Law Claims Based on Eye Drop Dispensers are Preempted,
October 4, 2017
• Deregulatory Agenda Notwithstanding, the Enforcement Side of the House is Open for Business,
July 27, 2017
• Another False Claims Act Case Dismissed in the Post-Escobar Landscape,
April 12, 2017
• FDA Rolls Out a New Form—You May Want to Pay Attention to This One,
September 15, 2016j
• District Court Dismisses PHO Lawsuit on Preemption Grounds,
March 15, 2016