Skip to main content

James C. Fraser, a former Associate Chief Counsel for Litigation at the U.S. Food and Drug Administration, has more than 16 years of experience in life sciences litigation, including FDA regulatory litigation and products liability and mass tort litigation.

In his five years at FDA, James represented the agency in civil litigation throughout the United States. This work included defending FDA against Administrative Procedure Act challenges to the agency’s decisions regarding pharmaceuticals, medical devices, and other FDA-regulated products, bringing civil enforcement actions against manufacturers of pharmaceuticals and other products for violations of the Food, Drug, and Cosmetic Act (FDCA), and drafting amicus curiae and other filings advocating FDA’s positions on federal preemption and preclusion.

In addition to his time at FDA, James has over 11 years of experience defending pharmaceutical and medical device manufacturers in products liability and mass tort litigation throughout the United States. This work has included briefing complex issues such as federal preemption, federal jurisdiction, admissibility of expert testimony under Daubert and Frye, punitive damages, and choice of law.

Capabilities

Experience

  • On behalf of FDA, won summary judgment or dismissal in three separate cases where generic prescription drug manufacturers sought Hatch-Waxman marketing exclusivity for their products.°
  • On behalf of FDA, won summary judgment when a prescription drug manufacturer challenged the agency’s denial of its request to re-classify its drug as a biological product under the Biologics Price Competition and Innovation Act.°
  • Served on a DOJ/FDA trial team that won a six-day trial in the Central District of California where the government obtained a permanent injunction preventing an over-the-counter drug manufacturer from selling its products.°
  • Via amicus curiae filings on behalf of FDA, won decisions from the U.S. International Trade Commission and the U.S. Court of Appeals for the Federal Circuit holding that the FDCA precluded a prescription drug manufacturer’s Lanham Act and Tariff Act claims against dietary supplement manufacturers.°
  • In private practice, wrote a post-trial motion that resulted in a 99.6% reduction of a $9 billion punitive damages verdict (reported to be the seventh largest punitive damages verdict in U.S. history).°
  • In private practice, had primary responsibility for legal briefing in four federal multi-district (MDL) proceedings, two state-wide coordinated proceedings, and many other federal and state cases throughout the country.°
  • In private practice, served as a member of on-site motions and/or witness preparation teams for ten multi-week jury trials (including MDL “bellwether” trials) in Minnesota, Missouri, New York, New Jersey, and Ohio.°

°The above representations were handled by Mr. Fraser prior to his joining Greenberg Traurig, LLP.

  • Associate Chief Counsel for Litigation, U.S. Food and Drug Administration – Office of the Chief Counsel, 2016-2021
  • U.S. Air Force – Judge Advocate General’s Corps, 1995-2001
    • Appellate Counsel, Air Force Appellate Counsel Division, 1999-2001
    • Trial Defense Counsel, Air Force Trial Defense Division, 1998-1999
    • Prosecutor, Office of the Staff Judge Advocate, Dover AFB, 1995-1998
  • Adjunct Professor, Written and Oral Advocacy, The University of Maryland Francis King Carey School of Law, 2019-2020

Recognition & Leadership

  • Recipient, FDA Office of the Commissioner, “Outstanding Service Award,” 2019
  • Recipient, U.S. Air Force, “Meritorious Service Medal,” 2001
  • Recipient, U.S. Air Force, “Commendation Medal,” 1998, 1999
  • Member, District of Columbia Bar Association, 1998-Present
  • Member, Maryland Bar Association, 1997-Present

Credentials

Education
  • J.D., with honors, University of Iowa College of Law
    • Associate Editor, Iowa Law Review
  • B.A., Michigan State University
Admissions
  • District of Columbia
  • Maryland