Kara Coen is Of Counsel in the Litigation Department of Paul Hastings and is based in the firm's Washington, D.C. office. Her practice focuses on counseling healthcare and life sciences companies, as well as lenders and investment firms, on complex regulatory, compliance, and transactional issues.
Prior to joining the firm, Ms. Coen practiced as the sole in-house healthcare and FDA regulatory counsel for a top financial institution, where she developed extensive experience advising on transactions spanning the healthcare and life sciences industrial spectrum. In this capacity, she counseled senior management, corporate finance risk teams, strategic business partners, and special clinical teams on regulatory, financial, and reputational risks in connection with cash flow, asset-based, and real estate lending matters involving pharmaceutical and medical device companies, healthcare service providers, hospitals and health systems, healthcare IT companies, and outpatient care centers. During this time, Kara evaluated a wide variety of financial and compliance risks associated with issues such as FDA manufacturing compliance, enforcement actions and product approvals, as well as federal and state government investigations, Corporate Integrity Agreements, HIPAA/data privacy compliance, and corporate compliance programs.
In addition, Ms. Coen has substantial private practice experience as a former white collar investigations and litigation associate at an international law firm. Kara advised healthcare providers and life sciences companies on a broad range of regulatory and compliance matters, including False Claims Act, Federal Trade Commission, and Foreign Corrupt Practices Act investigations, as well as qui tam and intellectual property litigation matters. Ms. Coen has considerable experience regarding white collar investigations and related criminal and civil actions, internal investigations, regulatory enforcement matters, and compliance counseling, in addition to complex commercial litigation and e-discovery management.
Ms. Coen received her J.D. from the University of Virginia School of Law in 2009 and her B.A. (magna cum laude and with departmental honors) from Washington & Lee University in 2004. She is admitted to practice in the District of Columbia and Massachusetts.
University of Virginia School of Law, J.D., 2009
Washington & Lee University, B.A. (magna cum laude), 2004
Panelist, Investment and M&A Opportunities in Healthcare Conference, Nashville, TN: "Healthcare Lenders Roundtable" (September 24, 2019)
Panelist, International Privacy + Security Forum, Washington, D.C.: "Privacy and Data Security Due Diligence in M&A" (April 5, 2019)
Panelist, Healthcare Compliance Association Regional Conference, Atlanta, GA: "Critical Developments to Share with Leadership Today" (January 25, 2019)