Overview
Jane H. Yoon is a partner in the Litigation practice of Paul Hastings and is based in the firm’s New York office. Ms. Yoon represents corporate entities and their executives in connection with government and internal investigations into allegations of potential violations of the federal anti-kickback statute, health care fraud, the Food Drug & Cosmetic Act, HIPAA, and the False Claims Act. These matters range from conduct surrounding patient support/assistance programs, specialty pharmacy arrangements, clinical trials and investigator-initiated studies, promotional communications, and the full range of interactions between manufacturers, prescribers, third-party vendors, patients, and payers. Ms. Yoon also handles matters relating to allegations of billing fraud and Medicare risk adjustment practices under Medicare Advantage.
A significant portion of her practice has been devoted to representing manufacturers, as well as senior principals, before the DOJ, HHS-OIG, various OIGs of federal agencies, and state attorneys general. Ms. Yoon also devotes substantial time assisting companies with undertaking proactive risk assessments and compliance program reviews, preparing for potential enforcement and/or qui tam activity, and provides day-to-day compliance counseling advice on patient assistance programs and promotional practices.
Prior to joining Paul Hastings, Ms. Yoon was an Assistant United States Attorney in the Health Care and Government Fraud Unit in the U.S. Attorney’s Office for the District of New Jersey for approximately seven years. Ms. Yoon led numerous investigations into health care fraud offenses, including investigations and prosecutions of fraud against the government and private health insurance plans, illegal kickback schemes, violations of the Federal Food, Drug & Cosmetic Act, False Claims Act cases, and the improper diversion of prescription drugs. She also prosecuted and tried several complex tax fraud offenses and cases involving fraud against various government agencies and private entities, and investigated and prosecuted the one of the first federal criminal cases involving compounding pharmacy fraud in the United States. An experienced trial attorney, Ms. Yoon recently served as trial counsel to a former Deutsche Bank trading desk supervisor in a month-long criminal LIBOR manipulation trial before the Chief Judge of the Southern District of New York.
Recognitions
- The Legal 500, Dispute Resolution - Corporate Investigations and White-Collar Criminal Defense: Advice to Corporates (2021)
- The Legal 500, Healthcare: Life Sciences (2021)
Education
- University of Michigan Law School, J.D., 2002 (Articles Editor, Michigan Law Review)
- Yale College, B.A., History, 1997
Representations
- Represented an opioid manufacturer in connection with a multi-district federal investigation and a qui tam complaint focusing on promotional practices and alleging potential violations of the anti-kickback statute and False Claims Act, resulting in a $7.55 million civil-only settlement in the District of New Jersey.
- Represented a company in connection with response to subpoenas from U.S. Attorney’s Offices and various federal agencies including HHS-OIG regarding claims for reimbursement of opioids and opioid use disorder treatments.
- Represented the founder of a genetic testing laboratory in connection with a multi-district federal investigation.
- Represented a biotech company in connection with potential whistleblower allegations relating to clinical trial and regulatory compliance matters.
- Represented a large pharmaceutical manufacturer in connection with a potential whistleblower threat relating to allegations of improper activity around the company’s patient support program.
- Represented a large Medicare Advantage organization in connection with internal investigations and qui tam complaints relating to Medicare risk adjustment practices.
- Represented a senior executive of a pharmaceutical manufacturer in connection with an investigation into donations to a co-pay assistance foundation in the District of Massachusetts.
- Represented a global pharmaceutical manufacturer in connection with third-party audits of vendors providing reimbursement support services.
- Represented a pharmaceutical manufacturer in connection with internal and federal investigations of fraud against its copay card program.
- Represented a global, multi-national pharmaceutical manufacturer in connection with an assessment of its charitable donations program and policies.
- Advised a large multi-national pharmaceutical manufacturer in connection with its assessment of patient support programs and policies relating to data governance and sharing.
- Trial counsel for a former Deutsche Bank trading desk supervisor in a criminal LIBOR manipulation case in the Southern District of New York.
Engagement & Publications
- Presenter, CBI’s Virtual Patient Support Services Congress Panel: "What to Watch: 2020 Compliance & Legal Trends" (October 27, 2020
- Presenter, CBI Specialty Pharmaceuticals Compliance Congress, "The Future of Biotech (CCO Discussion)" (September 2020)
- Co-Author, On the Heels of Significant FCPA Settlements, Past and Present Meet as Novartis Reaches FCA Settlements in Two Districts, Paul Hastings (July 16, 2020)
- Co-Author, As Enforcement Against Hoarding and Price Gouging Escalates Amidst the COVID-19 Crisis, What Corporate Compliance Can Do, Paul Hastings (April 28, 2020)
- Co-Author, Compliance in the Era of COVID-19 – Where and How Life Sciences and Health Care Companies Should Focus in the Era of Social Distancing, Paul Hastings (April 22, 2020)
- Moderator, CBI, Compliance Officer Panel: "Reboot Your Approach to Patient Support" (June 19, 2019)
- Moderator, CBI, Government Perspectives on High-Priority Risks for Patient Support Services (June 19, 2019)
- Panelist, CBI, Prosecutors’ Perspectives Panel: Examine the High-Priority Risk Areas for Biotech and Specialty Pharma (September 13, 2018)
- Author with Gary F. Giampetruzzi and Jessica R. Montes, Another Life Sciences Company Announces a Multi-Million Dollar Settlement in the U.S. Department of Justice’s Relentless Pursuit of Donations to Copay Assistance Charities, Law360.com (June 19, 2018)
- Moderator, CBI, Patient Assistance Programs and Reimbursement Hub Services Compliance – A New Wave of Enforcement Actions (April 23, 2018)
- Presenter, "Qui Tam & the False Claims Act: Future Trends and Developments", November 20, 2017
- Panelist, 18th Annual Pharmaceutical and Medical Device Compliance Congress, Managing an Internal Investigation under a CIA, DPA and a Data Analytics Failure (November 7, 2017)
- Panelist, AHLA Fraud and Compliance Forum, The Opioid Crisis - New Government Enforcement Initiatives and Future Implications for the Healthcare Industry (October 5, 2017)
- Author with Gary F. Giampetruzzi and Sandra Gonzalez, Against the Backdrop of a ‘National Emergency,’ Are Opioid Manufacturers Ready for the Enforcement Spotlight?, Bloomberg Law, Pharmaceutical Law Industry Report (August 25, 2017)
- Panelist, Assessing Emerging Risks and the Role for Compliance Across Market Access Activities, CBI’s 14th Annual Pharmaceutical Compliance Congress (April 2017)
- Panelist, Risks Associated with the Hub, CBI’s 14th Annual Pharmaceutical Compliance Congress (April 2017)
- Panelist, FCPA/Anti-Corruption Compliance in Life Sciences and Pharmaceutical Industry: A 2017 Update (LIVE Webcast – March 14, 2017)
- Presenter, "The Investigation of Albert Ades, M.D.," 2015 National Insurance Crime Bureau—DNJ Health Care Fraud Task Force Meeting (Newark, NJ), May 2015
- Presenter, "Prescriptions R Us," 2016 National Insurance Crime Bureau—DNJ Health Care Fraud Task Force Meeting (Newark, NJ), June 2016
- Panelist, American Conference Institute, Women Leaders in Life Sciences Law, Boston, June 2015
- Panelist, American Conference Institute, Women Leaders in Healthcare Law, D.C., September 2015
Involvement
- Law Clerk, Hon. Joseph A. Greenaway, Jr., Third Circuit Court of Appeals (United States District Court, District of New Jersey)