FacultyFaculty/Author Profile

James P. Ellison

Hyman, Phelps & McNamara, P.C.

Washington, DC, USA


Practice Areas

Health Care
Enforcement
Consumer Product Safety Commission
Education

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


Bar Admissions

District of Columbia
Maryland
Wisconsin
U.S. Court of Federal Claims



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.


Related Experience

• 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, March/April 2009
Hyman, Phelps & McNamara Issues Analysis Discussing the Implications of the Supreme Court's Wyeth v. Levine Decision, March 16, 2009

Speaking Engagements

ACI: National Forum on Pharmaceutical Pricing Litigation, October 2 - 3, 2012 Bolstering Trial Strategy in Litigation over AMP Calculations to Mitigate Exposure
FDLI Conference on Enforcement and Litigation, October 13 - 14, 2009 Enforcement in a Post-Wyeth, New Administration World

Blog Posts - see more blog entries

Paralyzed Veterans Is No More. Is Auer Next?, March 19, 2015
Former Officials of Peanut Corp of America Found Guilty; FDA Proposes to Require Supplier Verification Under the FSMA Preventive Controls Rule, September 22, 2014
Consumer Groups File Motion to Intervene in Vermont GE Labeling Litigation, July 24, 2014
DOJ Announces Significant Policy Shift on Electronic Recordings of Statements; Will Other Agencies Follow?, May 29, 2014
HP&M Comments on IND Guidance; Says FDA Lacks Authority to Impose Requirements on Non-drug Studies, April 8, 2014
James P. Ellison is associated with the following items:
Treatise  Treatise FDA Deskbook: A Compliance and Enforcement Guide
Treatise Chapters  Treatise Chapters FDA Administrative Actions - FDA Deskbook: A Compliance and Enforcement Guide, Tuesday, November 14, 2017
FDA Criminal Enforcement Actions - FDA Deskbook: A Compliance and Enforcement Guide, Tuesday, November 14, 2017
Issues Arising from Criminal Cases - FDA Deskbook: A Compliance and Enforcement Guide, Tuesday, November 14, 2017
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