Hyman Phelps and McNamara
 
Jennifer M. Thomas
Director
Photo of Jennifer M. Thomas

(202) 737-4280
jthomas@hpm.com
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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

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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   
•  Top Food and Drug Cases 2015 and Cases to Watch 2016: United States v. Quality Egg, LLC,  2016

•  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


Speaking Engagements   
•  FDA-Regulated Entities: Compliance and Enforcement Strategies, FDA Deskbook: A Compliance and Enforcement Guide, April 28, 2016


Blog Posts    -    see more blog entries
•  FDA Finalizes Product Classification Guidance,  October 3, 2017
•  Public Citizen Suit Highlights FDA’s Delays in Updating OTC Drug Monographs,  September 25, 2017
•  Fifth Circuit Upholds Summary Judgment for Solvay Pharmaceuticals in Off-Label and Anti-Kickback FCA Case,  September 20, 2017
•  Medical Device “Fraud on the FDA” Theory Might Be Viable in Minnesota, if Properly Pled,  September 6, 2017
•  First Circuit Holds that Identifying One Fraudulent Medicaid claim, with Projections, is Sufficient to Survive Motion to Dismiss in FCA Case,  August 3, 2017