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James P. Ellison: Lawyer with Hyman, Phelps & McNamara, P.C.

James P. Ellison

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Washington,  DC  U.S.A.
Phone(202) 737-4294

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Experience & Credentials
 

Practice Areas

  • Food and Drug Law
  • Litigation
  • Health Law
  • Health Insurance Portability and Accountability Act
  • Pharmacy Law
  • Controlled Substances Law
 
University Princeton University, Public Affairs, magna cum laude, 1991
 
Law SchoolUniversity of Virginia, J.D., 1994
 
Admitted1994, Pennsylvania (inactive); 2002, District of Columbia, U.S. Court of Appeals, Fourth Circuit and U.S. District Court for the District of Columbia; 2003, U.S. District Court, District of Maryland
 
BornPhiladelphia, Pennsylvania, July 23, 1969
 
Biography

Mr. Ellison works primarily on civil and criminal litigation matters, including pre litigation enforcement matters likely to lead to litigation.

Since joining the firm in 2007, Mr. Ellison has represented clients in a variety of litigation matters. For example, he has acted as lead national counsel for several pharmaceutical companies in Medicaid pricing enforcement actions brought by various states in federal and state courts; represented a pharmaceutical company in an action brought against the Drug Enforcement Administration (DEA) in the U.S. Court of Appeals; represented a pharmaceutical company in an action brought against the Food and Drug Administration (FDA) in federal district court; and defended a pharmaceutical company in a Lanham Act case brought by a competitor in federal court. Mr. Ellison also has assisted clients with government and internal investigations and compliance counseling.

Prior to joining the firm, Mr. Ellison was a Trial Attorney with the U.S. Department of Justice, Office of Consumer Litigation, and in that capacity handled litigation matters involving FDA, Federal Trade Commission (FTC), and Consumer Product Safety Commission (CPSC). In addition to working as a federal prosecutor, Mr. Ellison was also the Chief Compliance Officer and Regulatory Counsel for a District of Columbia government agency. Mr. Ellison received his undergraduate degree, magna cum laude, from Princeton University's Woodrow Wilson School of Public & International Affairs in 1991. He received his law degree in 1994 from the University of Virginia School of Law. From 1994-1995, Mr. Ellison served as a law clerk for the Honorable Diana Gribbon Motz of the United States Court of Appeals for the Fourth Circuit. Mr. Ellison is admitted to practice in the District of Columbia and various federal trial and appellate courts.

Articles / Publications

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

Blog Posts

The Hammer Falls on PCA; Indictment Could Raise Difficult Questions About Supplier Verification Under FSMA, February 25, 2013

New FDC Act Criminal Penalty for Intentional Drug Adulteration Receives Sentencing Commission Consideration, January 31, 2013

In Search Of (ISO) Court in Which to Challenge DEA ISO? The D.C. Circuit May Have an Answer for You, September 26, 2012

The Whole Ball of Wax: FDA Says Supreme Court Review of Holistic Candlers Case is Not Warranted, September 18, 2012

D.C. Circuit Affirms District Court Decision Striking Down FDA Regulation Requiring Graphic Warnings on Cigarette Packages, August 28, 2012

Lack of Regulatory Guidance Fatal to Some, But Not All Claims in AMP False Claims Act Case, July 18, 2012

Supreme Court to Regulatory Agencies: Due Process Requires "Fair Notice" of Agency Interpretations, July 1, 2012

Abbott's Resolution of Off-Label Allegations Has Familiar and New Elements to It, May 22, 2012

Supreme Court Decision Raises Interesting Questions Regarding Judicial Review of Agency Action, Provides Few Answers, March 23, 2012

Supreme Court To Decide When EPA and Perhaps Other Federal Agencies Can be Sued in Federal Court, January 17, 2012

Sentencing Hearings for Synthes Executives Suggest that Government May Try to Prove Fraud In Connection with Park Cases, December 22, 2011

Indictment of Former Glaxo In-House Attorney Dismissed, March 24, 2011

Court Upholds Exclusion of Former Purdue Executives, December 20, 2010

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

 
ISLN919335583
 

Documents by this lawyer on Martindale.com

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Recent Kellogg Class Action Settlement is a Reminder that Litigation Over Advertising Claims Often Comes in Several Waves
Katie Bond,James P. Ellison, May 31, 2013
You may not recall our prior April 2009 blog post about the FTC’s settlement with Kellogg over its marketing campaign for Frosted Mini-Wheats. To briefly recap, Kellogg had claimed that “its cereal was “clinically shown to improve kids’ attentiveness by nearly 20%.”...

New FDC Act Criminal Penalty for Intentional Drug Adulteration Receives Sentencing Commission Consideration
James P. Ellison, February 4, 2013
Earlier this month, the U.S. Sentencing Commission (the “Commission”) issued a Notice of Proposed Amendments to the U.S. Sentencing Guidelines, which are used by federal courts to determine sentences for criminal violations.

In Search Of (ISO) Court in Which to Challenge DEA ISO? The D.C. Circuit May Have an Answer for You
James P. Ellison, September 28, 2012
Traditionally, challenges to a Drug Enforcement Administration (“DEA”) immediate suspension order (“ISO”) have been litigated, in the first instance, in federal district courts. This is true even when the physician, pharmacy, distributor, wholesaler or other DEA registrant...

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Office Information

James P. Ellison
Hyman, Phelps & McNamara, P.C.
700 Thirteenth Street, N.W., Suite 1200
Washington, DC 20005-5929




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