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James C.Fraser

Senior Counselmoc.eniHnospmohT@resarF.semaJ
Washington, D.C.

O 202.973.2730

James C.Fraser

Senior Counsel

Focus Areas

Examples of James’ experience include:

Private practice experience

  • Assisting a biotechnology company in successfully challenging FDA’s denial of its request for orphan drug designation.
  • Conducting FDA-related due diligence for a client’s acquisition of a company that markets an OTC drug, dietary supplements, and cosmetics.
  • Developing federal preemption arguments that persuaded a potential consumer class action plaintiff to not file suit against an OTC drug manufacturer.
  • Advising drug manufacturers on responding to FDA Form 483s (Inspectional Observations) regarding cGMP issues.
  • Advising a drug manufacturer on issues relating to an FDA Risk Evaluation and Mitigation Strategy (REMS).
  • Advising a medical device manufacturer on FDA requirements for investigating possible device malfunctions.
  • Writing a post-trial motion that resulted in a 99.6% reduction of a $9 billion punitive damages verdict against the defendants in a pharmaceutical product liability trial (then reported to be the seventh largest punitive damages verdict in U.S. history).
  • Having primary responsibility for legal briefing in four federal multidistrict litigation (MDL) proceedings, two statewide coordinated proceedings, and many other federal and state cases throughout the country.
  • Serving as a member of on-site motions and/or witness preparation teams for 10 multi-week jury trials (including MDL “bellwether” trials) in Minnesota, Missouri, New York, New Jersey, and Ohio).

FDA experience

  • Obtaining summary judgment or dismissal for FDA in three cases in which generic drug manufacturers sought Hatch-Waxman marketing exclusivity for their products.
  • Obtaining summary judgment for FDA in a case in which a drug manufacturer challenged the agency’s denial of its request to reclassify its drug as a biological product under the Biologics Price Competition and Innovation Act.
  • Serving on a DOJ/FDA trial team that won a six-day trial in the Central District of California in which the government obtained an injunction preventing an OTC drug manufacturer from selling its products.
  • Drafting amicus curiae briefs for FDA that resulted in decisions from the U.S. International Trade Commission and 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.
  • Drafting FDA’s submission in support of a California administrative agency’s proposed regulation exempting coffee from the state’s Proposition 65 cancer-warning requirement. The submission explained that the FDCA would preempt such a warning; the regulation was subsequently adopted.
  • Obtaining dismissals of challenges to FDA labeling decisions regarding foods, cosmetics, and tobacco products.
  • Advising FDA officials on responding to Citizen Petitions requesting regulatory actions regarding medical devices and cosmetics.
  • “Importing FDA-Regulated Products: Compliance & Enforcement Issues,” Thompson Hine Webinar, November 2023
  • “Dissecting the Proposal for Transitional Coverage of Emerging Technologies,” Q1 Productions Medical Device Coverage & Reimbursement Conference, Chicago, IL, July 2023
  • “Post-Covid-19 Litigation Trends,” International Bar Association’s Annual Life Sciences Conference, Washington, D.C., June 2023
  • “FDA Under Fire: What Recent Cases Mean for FDA Regulation,” Food and Drug Law Institute’s Annual Conference, Washington, D.C., May 2023
  • “FDA 101 for Startups,” Thompson Hine Startups Streamlined Podcast Series, April 2023
  • “Opportunities to Convert Adverse Administrative Determinations into Successful Outcomes,” Q1 Productions Medical Device Coverage & Reimbursement Conference, Chicago, IL, July 2022
  • “Trends and Risks in Medical Device Enforcement Litigation,” Food and Drug Law Institute’s Annual Conference, Washington, D.C., June 2022
  • “Updates in Litigation Risks for FDA-Regulated Companies: Product Liability, Private Litigation, Consumer Class Actions, and More,” Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference, Washington, D.C., December 2021

Professional Associations

  • Food and Drug Law Institute (FDLI) (Medical Products Committee and Digital Health Planning Committee)
  • International Association of Defense Counsel (IADC)

Professional Activities

  • University of Maryland Francis King Carey School of Law, adjunct professor, Written and Oral Advocacy, 2019 and 2020 spring semesters


  • The University of Iowa College of Law, J.D., 1995,
    with distinction

    Iowa Law Review, associate editor; American Jurisprudence Award in Constitutional Law

  • Michigan State University, B.A., 1992

Bar Admissions

  • District of Columbia
  • Maryland

Court Admissions

  • U.S. District Court for the District of Columbia
  • U.S. District Court for the District of Maryland
  • U.S. Court of Appeals for the Third Circuit
  • U.S. Court of Appeals for the Fourth Circuit
  • U.S. Court of Appeals for the Sixth Circuit
  • U.S. Supreme Court
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