Heather O'Shea handles civil litigation and regulatory and compliance matters involving the health care industry. 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, 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 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 the Anti-Kickback Statute 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.
Experience
Leading laboratory services provider successfully resolves lengthy false claims case after obtaining partial summary judgment and multiple administrative victories
Throughout several years of active litigation, Jones Day represented a laboratory services provider in a case alleging that the laboratory company violated the Florida False Claims Act by (1) failing to bill its "usual and customary charge" under the State's argued interpretation of that term; and (2) offering steep discounts in order to induce referrals in violation of Florida's anti-kickback statutes.
Health system resolves False Claims Act qui tam lawsuit
Jones Day represented a health system in a qui tam action brought by a former physician employee alleging violations of the federal and Indiana False Claims Acts.
Manufacturer conducts internal investigation relating to sales and marketing practices
Jones Day advised a manufacturer in connection with an internal investigation related to sales and marketing practices, including practices related to nurse educators and field reimbursement specialists.
Hospice provider secures dismissal of False Claims Act case
Jones Day successfully represented a hospice provider in a Department of Justice Investigation spurred by a qui tam lawsuit brought under the False Claims Act.
Atlantic Health System acquires Hackettstown Regional Medical Center
Jones Day represented Atlantic Health System in the transfer of ownership of Hackettstown Regional Medical Center from Adventist HealthCare to Atlantic Health System.
Abbott purchases option to acquire Cephea Valve Technologies
Jones Day advised Abbott Laboratories in the providing of capital and securing of an option to purchase Cephea Valve Technologies, a private company developing a catheter-based mitral valve replacement therapy.
National retail pharmacy obtains dismissal of purported False Claims Act claims
Jones Day prevailed on behalf of a national retail pharmacy on motions to dismiss two qui tam suits brought under the federal False Claims Act, Anti-Kickback Statute, and Civil Monetary Penalties Law.
Manufacturer of medical equipment obtains dismissal of False Claims Act qui tam action related to patent applications
A manufacturer of medical equipment represented by Jones Day obtained dismissal of a False Claims Act qui tam action in which the relator alleged that the manufacturer lied on the patent applications for one of its medical products, making the patents invalid and unenforceable.
Canaccord Genuity, Cowen and Company, Oppenheimer, BTIG, and Stephens underwrite $65 million IPO by Avinger
Jones Day advised Canaccord Genuity Inc.; Cowen and Company LLC; Oppenheimer & Co. Inc.; BTIG, LLC; and Stephens Inc., as underwriters, in connection with the $65 million initial public offering by Avinger, Inc., a commercial-stage medical device company that designs, manufactures, and sells image-guided, catheter-based systems that are used by physicians to treat patients with peripheral arterial disease.
Fortune 500 life sciences company acquires medical device developer
Jones Day advised a Fortune 500 life sciences company in its acquisition of a developer of medical devices for approximately $250 million in cash.
University conducts internal review of Institutional Review Board
Jones Day conducted an internal review and assessment of the policies, procedures and practices of a university's Institutional Review Board (IRB) for human subject research.
LabCorp obtains complete dismissal of Virginia qui tam action alleging submission of false claims to Medicaid
In one of the first cases litigated under the Virginia Fraud Against Taxpayers Act, an analog to the federal False Claims Act, Jones Day represented Laboratory Corporation of America (LabCorp), a nationwide provider of health care diagnostic testing services.
LabCorp obtains dismissal of Georgia qui tam action alleging submission of false claims to Medicaid
Jones Day represented Laboratory Corporation of America (LabCorp), a nationwide provider of health care diagnostic testing services, in a case brought under the Georgia False Medicaid Claims Act, an analog to the federal False Claims Act.
Pharmaceutical and device manufacturers advised on Physician Payments Sunshine Act
Jones Day has been advising several pharmaceutical and device manufacturers on the reporting of payments or other transfers of value under the Physician Payments Sunshine Act, including analysis of specific scenarios involving subsidiaries, foreign and domestic, co-development arrangements, research activities, licensing and material transfer arrangements, and other payments or transfers of value related to covered recipients.
Pharmaceutical manufacturer conducts internal investigation related to clinical research collaboration
Jones Day advised a pharmaceutical manufacturer in connection with an internal investigation related to an international clinical research collaboration with academic medical centers and other research sites.
Medical center successfully defends "unilateral monitoring" review by OIG
Jones Day successfully represented a community medical center in what was the OIG's first "unilateral monitoring review."
Community hospital resolves investigation regarding medical necessity of cardiology procedures
Jones Day represented a community hospital in an investigation by the Department of Justice and HHS OIG.
Health system conducts compliance effectiveness review
Jones Day conducted a compliance effectiveness review for a multi-hospital system.
Loyola University finalizes sale of academic medical center to Trinity Health
Jones Day represented Loyola University of Chicago in the sale of its affiliates, Loyola University Health System, Loyola University Medical Center, and Gottlieb Memorial Hospital to Trinity Health, a Novi, Michigan-based Catholic hospital system.
Pharmaceutical and device manufacturers conduct compliance risk assessment
Jones Day conducted a compliance risk assessment of two manufacturers' existing compliance programs.
Additional Publications
- September 21, 2017Court Overreaches in Requiring Medical Necessity, Medical Laboratory Observer
Speaking Engagements
- February 23, 2017U.S. Business Outlook in the New Administration Transition in the Legal Trenches: How Trump Appointees Could Shape the Judiciary and Influence Enforcement Priorities
- December 8, 2016The Attorney-Client Privilege and Work Product Doctrine: What In-House Counsel Need To Know
- September 22, 2016Emerging Enforcement Trends and Developments
- May 13, 2014Employment Issues and Retaliation Claims: Strategies and Risk Management False Claims Act Institute
- December 11, 2013FDLI Enforcement, Litigation and Compliance Conference - Legal Issues Keeping In-house Counsel Up at Night
- November 15, 2012Latest Trends With The Corporate Whistleblower: What In-House Counsel and Corporate Compliance Officers Should Be Prepared For, North Shore Wine Tasting and CLE
- March 28, 2012Health Care 2012: Issues and Answers for a Complex Industry
- March 28, 2012Increased Scrutiny on Pharmaceutical and Medical Device R&D Activities: The Impact on Clinical Research Sites
- October 21, 2011Counsel and Executives in the Cross Hairs? 15th Annual Health Care Compliance Forum
- October 21, 2011Stark: Mitigating Risks and Strategies in Response to the Self-Disclosure Protocol, 15th Annual Health Care Compliance Forum
- October 19, 2011Trends in Compliance and Government Enforcement, 15th Annual Health Care Compliance Forum
- March 15, 2011Counsel in the Cross Hairs? Lessons Learned From Recent Prosecutions, Health Care Compliance and Enforcement Forum
- December 2, 2010Handling Government Inquiries-Identifying and Managing Risks
- Loyola University Chicago (LL.M. in Health Law 1999); Loyola University New Orleans (J.D. 1995); Texas Christian University (B.S. 1992)
- Illinois, Texas, District of Columbia, and U.S. District Court for the Northern District of Illinois
- Extern, United States Attorney's Office, Criminal Division, Northern District of Texas, Fort Worth (Summer 1993)
Chambers USA (2014, 2015, 2017, and 2018)
The Best Lawyers in America (2016, 2017, 2018, and 2019)
Selected for Nightingale's Healthcare News 2007 List of Outstanding Hospital Lawyers