Heather M.O'Shea

Heather O'Shea handles civil litigation and regulatory and compliance matters involving the health care industry and is co-leader of the Firm's Health Care & Life Sciences Practice. For more than 20 years she has represented health care providers, pharmaceutical and device manufacturers, and other health care entities in matters 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 significant experience conducting internal investigations, representing clients in voluntary disclosures, and counseling clients on refunds to Medicare. Heather also has extensive experience advising clients on compliance program development, implementation, and conducting assessments of existing compliance programs.

Heather's recent representations include 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 DOJ where the allegations focused on medical necessity.

Heather is a member of the American Health Lawyers Association, the American Bar Association, and the Illinois Association of Healthcare Attorneys.