Coleen W. Hill

Associate

  • Coleen W. Hill
  • Phone: +1 215 979 1164

    Import to Address Book

  • Duane Morris LLP
    30 South 17th Street
    Philadelphia, PA 19103-4196
    USA
  • Duane Morris LLP
    1201 North Market St, Suite 501
    Wilmington, DE 19801
    USA

Coleen W. Hill is a trial attorney whose practice focuses on representing clients in the Life Sciences industry in complex commercial, regulatory, and products liability disputes.  Ms. Hill has extensive experience litigating matters involving medical products regulated by the Food and Drug Administration (FDA) and the Federal Trade Commission, as well as issues arising under the Federal Food, Drug, and Cosmetic Act.  Her experience includes, for example, representation of a defendant in one of the country’s largest multidistrict litigations involving a widely-used pharmaceutical product.

Ms. Hill also advises companies on regulatory compliance issues and assists with responding to regulatory actions, including FDA Form 483s and Warning Letters.  She counsels pharmaceutical companies, biologics manufacturers, medical device companies, and cosmetic companies on complex issues arising under state and federal regulations.

Admitted to practice in both Pennsylvania and Delaware, Ms. Hill also litigates corporate governance disputes (including stockholder class and derivative litigation), statutory actions arising under Delaware corporate and alternative entity laws, and complex contractual disputes stemming from various corporate transactions. 

Ms. Hill holds a leadership role in Duane Morris’s Life Sciences and Medical Technologies industry group and actively monitors, publishes, and presents on developing FDA issues affecting Life Sciences industry clients.  She serves on a planning committee for the Food and Drug Law Institute and manages Duane Morris’s role as a member of the Editorial Board of the Food and Drug Law Journal

Ms. Hill serves on the attorney Recruitment and Retention Committee for Duane Morris’s Philadelphia office.  She is a 2016 cum laude graduate of Villanova University School of Law, where she was managing editor of production for the Villanova Law Review, and a summa cum laude graduate of Southern Illinois University. 

Admissions

  • Pennsylvania
  • Delaware
  • U.S. District Court for the Eastern District of Pennsylvania
  • U.S. District Court for the District of Delaware

Education

  • Villanova University Charles Widger School of Law, J.D., cum laude, 2016
    - Managing Editor of Production, Villanova Law Review
  • Southern Illinois University, B.A., summa cum laude, 2013

Experience

  • Duane Morris LLP
    - Associate, 2020-present
  • Morris, Nichols, Arsht & Tunnell LLP
    - Associate, 2016-2020

Professional Activities

  • Editorial Review Board for the Food and Drug Law Journal Vol. 77, Issue 4, 2022
  • Food and Drug Law Institute
    - New to FDA Law and Regulation Planning Committee

Selected Publications

Selected Speaking Engagements

  • Speaker, "When Things Go Wrong: Navigating Enforcement When the FDA, SEC, and DOJ Are All Involved," MassMEDIC Regulatory Roundup, November 15, 2023
  • Moderator, “Business and Legal Trends Impacting Emerging Technologies: How to Protect IP in an Increasingly Challenging Legal Environment,” Duane Morris Life Sciences GC Bootcamp Series, May 23, 2023
  • Speaker, "Recent Developments on the 'Fraud on the FDA' Theory of False Claim Liability," MassMedic Regulatory Roundup Event, Webinar, February 16, 2023
  • Speaker, "When Innovation Outpaces Regulation," MassMEDIC Annual Conference, December 6, 2022