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. Kara is a Member of the American Health Law Association.
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 and Life Sciences Private Equity and Finance Conference, Chicago, IL: "Best Practices for Investors Assessing Litigation and Regulatory Issues in Provider Services Transactions" (February 20, 2019)
Panelist, Healthcare Compliance Association Regional Conference, Atlanta, GA: "Critical Developments to Share with Leadership Today" (January 25, 2019)
Panelist, Emerging Biopharmaceutical Therapies Webinar Washington, D.C.: "Hypotheticals and a Look into the Future" (September 27, 2018)
As in-house counsel for a top national commercial bank, served as the enterprise-wide healthcare and FDA regulatory attorney and subject-matter expert on the False Claims Act. In this capacity, advised on and analyzed healthcare regulatory risks for over 450 middle market cash-flow, asset-based, and life science transactions for customers in all sectors of the healthcare industry, including:
A private equity sponsor's acquisition of a national middle-market pharmacy benefit manager focused on commercial clients.
A distressed loan regarding a provider of residential behavioral health services for individuals with significant intellectual and developmental disabilities.
A private equity sponsor's acquisition of a leading national contract manufacturer of gummy vitamins and supplements.
A direct lending opportunity involving a manufacturer of human tissue biologic products for surgical, non-operative, and specialty care purposes
The ongoing assessment of FDA manufacturing and quality enforcement actions regarding a manufacturer of generic human and veterinary drug products.
A private equity sponsor's acquisition of a radiology practice group under investigation by the DOJ.
Defended one of the country's largest hospital and healthcare services providers in a nationwide parallel criminal and civil investigation by DOJ and HHS-OIG of medical necessity and quality-of-care allegations.
Represented a multinational pharmaceutical company in a civil False Claims Act investigation by DOJ and HHS-OIG regarding alleged violations of the Anti-Kickback Statute and improper sales and marketing practices.
Represented a major national hospital system in the full-phase FTC Hart-Scott-Rodino investigation of a $135 million hospital acquisition that resulted in clearance without conditions.