Coleen W. Hill is a trial attorney whose practice focuses on representing clients in the Life Sciences industry in complex commercial and regulatory 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.
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. In addition, Ms. Hill represents clients and employers in commercial and business tort disputes involving restrictive covenants, trade secrets, and unfair competition.
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 is a member of the Food and Drug Law Institute’s 2025 Food and Drug Law Journal Advisory Board.
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
Honors and Awards
- Litigator of the Week Runner-Up, AmLaw Litigation Daily, December 13, 2024
Professional Activities
- Food and Drug Law Institute
- 2025 Food and Drug Law Journal Advisory Board
Representative Matters
Glass, et al. v. B. Braun Medical Inc., et al., Case No. 210500315 (Philadelphia Cty., Pa Dec. 5, 2024). Obtained a defense verdict on behalf of B. Braun, an international medical technology company, after a five-week trial in the Philadelphia Court of Common Pleas. Plaintiff sought damages, including punitive damages, on counts of negligence, gross negligence, willful and wanton misconduct, strict liability, and civil conspiracy, claiming her husband developed leukemia from exposure to ethylene oxide allegedly emitted from B. Braun’s facility in Allentown, Pennsylvania. The jury found B. Braun not liable on all counts.
Listrak Inc. v. DiClemente, et al., No. CI-24-03536 (Lancaster Cty., Pa Aug. 28, 2024). Obtained a consent injunction order on behalf of Listrak against one of its former senior sales leaders and her new employer in a non-compete and misappropriation of trade secrets action.
- Represented the Stockholders’ Representatives of a pharmaceutical company seeking more than $200 million in damages related to the acquiring company’s failure to pay a “milestone” payment related to FDA approval of a biological drug.
NSM Insurance Group v. Nasman, et al., Case No. 2022-06310 (Montgomery Cty., Pa. May 20, 2022). Obtained a denial of a motion for a temporary restraining order filed by the plaintiff against its former underwriter and his new employer in a non-compete action.
In re: Valsartan, Losartan, and Irbesartan Products Liability Litigation (MDL No. 2875). Represented a generic active pharmaceutical ingredient manufacturer, finished dose manufacturer, distributor, and retailers in the more than 1000 products liability and 18 consumer class fraud class actions that alleged bodily injury and economic loss claims arising out of an alleged nitrosamine “contaminant” in valsartan.
ECBM LP v. Brian M. Chance, Civ. Action No. 20-0830 (E.D. Pa. Oct. 15, 2020). Secured denial of motion for a preliminary injunction on behalf of former ECBM employee who joined Stephens Insurance, finding that ECBM failed to establish that it had more than a negligible likelihood of success on the merits of its claims in a non-compete and misappropriation of trade secrets action.
Selected Publications
- Co-author, "Health and Human Services Issues Final Rule on Research Misconduct," Duane Morris Alert, November 25, 2024
- Co-author, "FDA Issues Guidance on Remote Clinical Trial Activities," Duane Morris Alert, October 21, 2024
- Co-author, "FDA Issues Draft Guidance on Predetermined Change Control Plans for Medical Devices," Duane Morris Alert, September 23, 2024
- Co-author, "FDA Finalizes New Rule for Lab-Developed Tests," Duane Morris Alert, May 20, 2024
- Co-author, "FDA Warning Letters Explained: An Opportunity, Not a Threat," Duane Morris Alert, November 21, 2023
- Co-author, "FDA Issues Draft Guidance on Pre-market Submissions for Patient-Matched Guides to Orthopedic Implants," Duane Morris Alert, August 16, 2023
- Co-author, "Beauty and Personal Care Products Post-MoCRA Regulatory Compliance Checklist," Lexis Nexis Practical Guidance, June 2023
- Author, "Summary of the Director’s Update for FDA’s Center for Drug Evaluation and Research," FDLI News, May 18, 2023
- Co-author, "FDA Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," Duane Morris Alert, June 1, 2023
- 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, "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