Heather M.O'Shea

Partner

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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 victoriesThroughout 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 lawsuitJones 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 practicesJones 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 caseJones 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 CenterJones 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 TechnologiesJones 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 claimsJones 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 applicationsA 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 AvingerJones 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 developerJones 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 BoardJones 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 MedicaidIn 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 MedicaidJones 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 ActJones 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 collaborationJones 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 OIGJones 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 proceduresJones Day represented a community hospital in an investigation by the Department of Justice and HHS OIG.
  • Health system conducts compliance effectiveness reviewJones Day conducted a compliance effectiveness review for a multi-hospital system.
  • Loyola University finalizes sale of academic medical center to Trinity HealthJones 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 assessmentJones Day conducted a compliance risk assessment of two manufacturers' existing compliance programs.
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    July 2019 Jones Day Publications

    D.C. Circuit Rejects Novel Theory of Reverse False Claims Liability for Reporting Violations

    May 2019 Jones Day Publications

    False Claims Act Update: DOJ Releases Guidelines for Cooperation Credit and Reduced Penalties

    December 2018 Alerts

    Department of Justice Moves to Dismiss FCA Cases Involving Patient Support Services

    December 2018 Commentaries

    Public Branding, the OIG's New Method of Punishing Health Care Entities?

    November 2018 Alerts

    Sunshine Act Reporting Requirements Expanded to Physician Assistants and Advance Practice Nurses

    November 2018 Commentaries

    D.C. District Court Vacates 60-Day Medicare Advantage Overpayment Rule

    October 2018 Alerts

    Pharmaceutical Company Agrees to $625 Million False Claims Act Settlement

    September 2018 Commentaries

    Ninth Circuit Clarifies Import of Escobar in False Claims Act Litigation

    February 2018 Commentaries

    DOJ Pursues PE Firm Based on Portfolio Company's Alleged Payment of Kickbacks

    January 2018 Commentaries

    2017 Statistics Again Show Massive Recoveries in False Claims Act Cases
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    Speaking Engagements

    • February 23, 2017
      U.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, 2016
      The Attorney-Client Privilege and Work Product Doctrine: What In-House Counsel Need To Know
    • September 22, 2016
      Emerging Enforcement Trends and Developments
    • May 14-15, 2015
      2015 Health Care Labor & Employment Symposium
    • May 13, 2014
      Employment Issues and Retaliation Claims: Strategies and Risk Management False Claims Act Institute
    • May 6, 2014
      The Continuing Expansion of Health Care Enforcement by U.S. and International Authorities: Key Developments and Implications for the Future
    • December 11, 2013
      FDLI Enforcement, Litigation and Compliance Conference - Legal Issues Keeping In-house Counsel Up at Night
    • April 9-10, 2013
      Jones Day 2013 Chicago Health Care Conference
    • November 15, 2012
      Latest 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, 2012
      Increased Scrutiny on Pharmaceutical and Medical Device R&D Activities: The Impact on Clinical Research Sites
    • March 28, 2012
      Health Care 2012: Issues and Answers for a Complex Industry
    • March 28, 2012
      Healthcare 2012: Issues & Answers For A Complex Industry
    • October 21, 2011
      Stark: Mitigating Risks and Strategies in Response to the Self-Disclosure Protocol, 15th Annual Health Care Compliance Forum
    • October 21, 2011
      Counsel and Executives in the Cross Hairs? 15th Annual Health Care Compliance Forum
    • October 19, 2011
      Trends in Compliance and Government Enforcement, 15th Annual Health Care Compliance Forum
    • March 15, 2011
      Counsel in the Cross Hairs? Lessons Learned From Recent Prosecutions, Health Care Compliance and Enforcement Forum
    • December 2, 2010
      Handling Government Inquiries-Identifying and Managing Risks
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