Heather M. O'Shea

Heather O'Shea handles civil litigation and regulatory and compliance matters in the pharmaceutical, medical device, biotech, and health care industries. She is a co-leader of the Firm's Health Care & Life Sciences Practice. For more than 20 years she has represented clients in federal and state government investigations and litigation involving fraud and abuse enforcement, including the False Claims Act (FCA), the Anti-Kickback Statute (AKS), Stark Law, and Medicare and Medicaid reimbursement. Heather represents clients on regulatory and compliance matters involving Medicare and Medicaid, fraud and abuse laws, reimbursement regulations, the Physician Payments Sunshine Act (Open Payments), clinical research compliance, and U.S. Food & Drug Administration (FDA) regulations. She has extensive experience conducting internal investigations, handling voluntary disclosures, and counseling clients on refunds to Medicare. Heather also has significant experience advising clients on compliance program development, implementation, and conducting assessments of existing compliance programs.

Heather's representations include defending several institutions being investigated by the National Institutes of Health (NIH) in connection with its focus on foreign influence on research integrity, defending a medical device manufacturer in a successful motion to dismiss an FCA case premised on alleged invalidated unenforceable patents, obtaining dismissal of qui tam actions in Virginia and Georgia federal courts that alleged the submission of false clams due to purported violations of Medicaid billing requirements, and conducting an internal investigation for a manufacturer relating to compliance with AKS in connection with discounting and sales and marketing practices. She also has represented multiple hospitals in FCA cases brought by the Department of Justice (DOJ) where the allegations focused on medical necessity.