Coleen W. Hill practices in the area of litigation, representing clients in a variety of complex commercial disputes. Ms. Hill has experience representing companies, officers and directors in expedited and non-expedited matters, including contractual disputes, statutory matters arising under Delaware corporate and alternative entity laws, fiduciary duty litigation and derivative shareholder litigation. She also has experience representing clients in commercial and business tort disputes, with an emphasis on non-compete, trade secrets and unfair competition litigation.
Additionally, Ms. Hill has helped pharmaceutical companies, biologics manufacturers, medical device manufacturers and pharmacies navigate the complex challenges faced by state and federal regulation for their industries. She also has experience representing specialty pharmacies in successful negotiations with Pharmacy Benefit Managers, including overturning decisions to suspend or terminate the pharmacies from insurance networks, negotiating reimbursement rates, and reversing claims rejections for high-dollar specialty medications.
Ms. Hill is 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 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
- Food and Drug Law Institute
- New to Food and Drug Law Planning Committee
Selected Publications
- Co-author, "FDA Issues Final Guidance on Clinical Decision Support Software," Duane Morris Alert, October 21, 2022
- Co-author, "FTC Publishes Proposed Changes to Guides Concerning the Use of Endorsements and Testimonials in Advertising," Duane Morris Alert, June 28, 2022
- Co-author, "FDA Issues Final Guidance on Initiation of Voluntary Recalls," Duane Morris Alert, March 16, 2022
- Co-author, "FDA Issues Draft Guidance on Content of Premarket Submissions for Device Software Functions," Duane Morris Alert, December 6, 2021
- Co-author, "FDA Issues Final Guidance on Form and Content of Unique Device Identifier Labeling System," Duane Morris Alert, July 26, 2021
- Co-author, "FDA Issues Final Guidance on Post-Approval Chemistry, Manufacturing and Controls Changes to Biologics," Duane Morris Alert, June 28, 2021
- Co-author, "Oklahoma to Begin Enforcing Challenged Patient Right-to-Choose Pharmacy Law," Duane Morris Alert, April 27, 2020
Selected Speaking Engagements
- Speaker, "Recent Developments on the 'Fraud on the FDA' Theory of False Claim Liability," MassMedic Reguatory Roundup Event, Webinar, February 16, 2023
- Speaker, "When Innovation Outpaces Regulation," MassMEDIC Annual Conference, December 6, 2022