Overview
Karen Owen Gibbs is the Partner-In-Charge of the Chicago Healthcare practice.
Karen advises healthcare and life sciences organizations, investors and lenders on operational, regulatory and enforcement issues. She helps clients identify opportunities to maximize their potential in the ever-evolving regulatory landscape and works to proactively mitigate risks associated with healthcare regulations and enforcement matters in order to resolve issues and implement compliance measures.
Karen represents a number of high-profile private equity firms who invest in healthcare and life sciences companies. She has led the regulatory team on recent transactions involving behavioral health, telemedicine, telepharmacy, home infusion pharmacy, home health, specialty pharmacy, pharmacy wholesale distribution, pharmacy reverse distribution, 503B outsourcing, pharmaceutical manufacturing, employer onsite and near site care, pharmacy benefit management (“PBM”), contract research and manufacturing in the pharma/biotech space, health care navigation, physical medicine management and global claims management.
As former Vice President and Senior Counsel at CVS Health, Karen has an extensive background in licensing, regulatory, compliance, enforcement and policy issues. She counsels clients on internal investigations and enforcement actions related to pharmacy law issues, Drug Enforcement Administration (DEA) actions and reimbursement matters. Karen also advises on a variety of related state issues, such as reporting under the Prescription Drug Monitoring Program (PDMP) requirements.
Results
• Led the regulatory team on a wide variety of health services and life sciences transactions. Representative clients include The Carlyle Group, General Atlantic, LLC and Kinderhook Industries, LLC
• Provided strategic counsel regarding business and operational opportunities for industry clients
• Led teams to develop compliance programs that address DEA, pharmacy, fraud and abuse, privacy and other health law issues, as well as meet requirements imposed by government settlements
• Represented clients in negotiations with governmental authorities regarding proposed business plans, compliance matters and enforcement issues
• Led internal investigations related to pharmacy law issues, DEA and related state issues
Recognitions
- The Best Lawyers in America, Healthcare Law, Chicago, 2020 to 2024
- American Health Lawyers Association, Pro Bono Champion
- McDermott Will & Emery, Award for Outstanding Achievement and Commitment to Pro Bono and Volunteer Service, 2018
Community
- American Health Lawyers Association, Health Care Reform Task Force, vice chair
- Illinois District 101, School Board, president
- Rotary International
Credentials
Education
University of Virginia School of Law, JD, Order of the Coif, 1992
University of Virginia, MA, 1989
Georgetown University, BSFS, 1987
Admissions
Illinois
