FacultyFaculty/Author Profile

Jennifer M. Thomas

Hyman, Phelps & McNamara, P.C.

Washington, DC, USA


Jennifer M. Thomas works primarily on government investigations, civil and criminal litigation, and enforcement matters. As part of her practice, Ms. Thomas assists drug, medical device, food, dietary supplement, and cosmetic companies with managing responses to warning letters, subpoenas, civil investigative demands, and proposed consent decrees. She also advises clients on a range of FDA, FTC, and CPSC regulatory issues, including advertising and promotion, and represents clients before the National Advertising Division (NAD) and the Electronic Retailing Self-Regulation Program (ERSP).

Ms. Thomas has worked in private practice in the food and drug, and advertising fields since 2007, and joined Hyman, Phelps & McNamara P.C. in 2011. While in law school, Ms. Thomas participated in the Institute for Public Representation's First Amendment and Media Law Project, and interned for the Maryland Office of the Public Defender.


Representative Matters

• Successfully challenged FDA under the Administrative Procedure Act based on an arbitrary and capricious product classification decision.
• Defended a large medical device company in a civil False Claims Act case and parallel criminal investigation.
• Helped a medical device company respond to a HIPAA subpoena.
• Assisted a dietary supplement company with its response to a civil investigative demand requiring the production of advertising substantiation.

Awards & Recognition

• DC Super Lawyer, Rising Stars, 2015

Articles / Publications

FDA and Product Jurisdiction: Time for Reforms, February 1, 2016
Significant Settlements, Top 20 Food and Drug Cases, 2013 & Cases to Watch, 2014, January 2014

Blog Posts - see more blog entries

HRSA Loses the Battle, and Maybe the War, Over the Orphan Drug Rule, October 15, 2015
A Court’s Contempt for the Government in Bayer, October 5, 2015
Bayer Scores a Big Win in Action Involving Dietary Supplement Claim Substantiation, October 1, 2015
FINALLY! Multiple Generic Companies Receive FDA Final Approval to Market Generic Versions of Celebrex®, February 12, 2015
Basic Research and the "Reasonable Basis" Standard, December 29, 2014


Education

J.D., cum laude, Georgetown University Law Center
B.A., summa cum laude, German and Political Science, St. Mary's College of Maryland

Bar Admissions

District of Columbia
Virginia
Jennifer M. Thomas is associated with the following items:
Treatise Chapters  Treatise Chapters Other Authorities Governing FDA-Regulated Entities - FDA Deskbook: A Compliance and Enforcement Guide, Tuesday, November 14, 2017
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