Karla L. Palmer Director 202-737-7542
Karla L. Palmer

Overview

With 25 years’ experience as a litigator, Karla Palmer’s focus at Hyman Phelps is on DEA and FDA enforcement and litigation matters.  Ms. Palmer advises clients throughout the supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of issues including DEA and FDA regulations and guidance, government inspections (including Form 483s) and investigations, warning letters, consent decrees, and administrative and federal proceedings.  She has also handled administrative proceedings at DEA involving, but not limited to, registrant revocation actions, including the appeal of those matters in federal courts.  In addition, she has written about and addressed industry audiences across the country on all aspects of the passage and implementation of the 2013 Drug Quality and Security Act including both compounding and supply chain issues, its guidance documents, and implementing regulations.  She is well-versed in compounding laws, regulations and guidance, and regularly counsels clients on these topics.

Over the course of her career, Ms. Palmer has also been involved in all aspects of general commercial litigation matters. She has served as trial counsel in federal, state, and administrative courts in the District of Columbia, Florida, Illinois, Maryland, New York, Nevada, Pennsylvania, Kansas, Virginia, and before the Court of Federal Claims, the U.S. Tax Court, and Federal Energy Regulatory Commission (FERC). She also has significant arbitration and mediation experience.

Before joining Hyman, Phelps & McNamara in 2010, Ms. Palmer was a partner at a large international law firm where she was head of the Washington, D.C. trial department and co-partner-in-charge of its national recruiting program. Following law school, Ms. Palmer clerked for the Honorable Claude M. Hilton, former Chief Judge of the U.S. District Court for the Eastern District of Virginia, Alexandria Division. She has served as both lead and local counsel in the Eastern District of Virginia.

While in law school, Ms. Palmer was an associate editor of The University of Richmond Law Review, a member of the McNeill Law Honor Society, and a legal writing teaching assistant.

Ms. Palmer is an immediate past member of the Board of Directors of the Law School Alumni Association at the University of Richmond, and is a former board member of Chattering Children, a nonprofit that provides speech and language education, therapy, and services to hearing impaired children throughout the Washington, D.C. area.

Education & Admissions

Education

J.D., cum laude, University of Richmond School of Law
B.A., Economics and Government, College of William & Mary

Admissions

District of Columbia
Virginia
U.S. District Courts for Eastern and Western Districts of Virginia
U.S. District Court for the District of Columbia
U.S. Bankruptcy Courts for the Eastern and Western Districts of Virginia
U.S. Court of Appeals for the District of Columbia Circuit
U.S. Court of Appeals for the Fourth Circuit
U.S. Court of Federal Claims
U.S. Tax Court

Experience

  • Provides counsel on DEA registration matters, investigations, and enforcement actions to registrants throughout the drug supply chain.
  • Advises on the regulation of listed chemicals, including pre-cursor ingredients used in the manufacture of controlled substances.
  • Provides guidance on business procedures concerning DEA registration, record keeping and reporting, and security requirements.
  • Participates in administrative and judicial proceedings involving DEA and FDA matters. Counsels clients on FDA inspections including responding to FDA Form 483s and warning letters with particular focus on compounding pharmacies and outsourcing facilities.
  • Counsels outsourcing facilities and compounding pharmacies concerning compliance and enforcement matters.
  • Participates in litigation relating to approval of certain prescription drugs and medical devices.

Honors & Awards

  • Law School Alumni Board of Directors University of Richmond
  • Permanent Member Judicial Conference for the Fourth Circuit 

Speaking Engagements

  • Co-Presenter, Law Line Course, Current Trends in DEA Diversion-Related Enforcement, available April 2018
  • Planning Committee Chair, Food and Drug Law Institute: Drug Quality and Security Act Conference,  November 15, 2017
  • Moderator, DQSA, Title II, Licensure of Wholesale Distributors and 3PLs: Where Does FDA Stand, Where do States Stand, What about VAWD, and What Can you Do about It?, Food and Drug Law Institute: Drug Quality and Security Act Conference, November 15, 2017
  • Speaker, American Society for Pharmacy Law; Developments in Pharmacy Law Seminar XXVII, What’s Now in the Mix? Compounding Four Years After NECC and the DQSA, November 2-5, 2017
  • Speaker, Webinar,  Compounding Still In the Mix: Title I of the DQSA, the Compounding Quality Act, Three Years Later, Food and Drug Law Institute, May 18, 2017
  • Co-Presenter, 20th Annual Controlled Substance and State Regulatory Conference, Legal Updates and Insights: DEA in 2016-2017, April 26-28, 2017
  • Co-Presenter, International Vein Congress Symposium, Presentation on Compounded Drug Products, April 20-22, 2017 
  • Co-Presenter, Law Line Course, A Guide to DEA Administrative Actions and Hearings, April 2017
  • Co-Presenter, 19th Annual Controlled Substances & State Regulatory Conference (IMS Health), Drug Quality and Security Act Title II: Drug Supply Chain Security Act, Legal Update, April 27-29, 2016
  • Co-Presenter, Food and Drug Law Institute – Drug Quality and Security in 2016, Recent FDA Guidance and Enforcement Discretion, February 23, 2016
  • Co-Presenter, Food and Drug Law Institute, Drug Compounding Panel, “Drug Quality and Security in 2016″, January 26, 2016
  • Co-Presenter, Federal Bar Association Annual Litigation Conference, Hot Topics in Litigation, October 27, 2015
  • Co-Presenter, Pennsylvania Bar Institute’s (PBI) Health Law Institute, ABCs of DEA Enforcement, March 13, 2015
  • FDLI and the University of Maryland Schools of Law and Pharmacy Present Emerging Issues in FDA Law: Implementation of DQSA: FDA’s Interim Guidance For Human Drug Compounding Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act, December 3, 2014
  • Co-Presenter, Association of Corporate Counsel, Health Law Committee, Recent DEA Enforcement Trends, August 6, 2013
Education

J.D., cum laude, University of Richmond School of Law
B.A., Economics and Government, College of William & Mary

Admissions

District of Columbia
Virginia
U.S. District Courts for Eastern and Western Districts of Virginia
U.S. District Court for the District of Columbia
U.S. Bankruptcy Courts for the Eastern and Western Districts of Virginia
U.S. Court of Appeals for the District of Columbia Circuit
U.S. Court of Appeals for the Fourth Circuit
U.S. Court of Federal Claims
U.S. Tax Court

Practice Areas
Industries
FDA Regulatory Categories