Avia M. Dunn

Ms. Dunn advises clients on matters related to compliance with fraud and abuse laws, HIPAA privacy restrictions and industry codes related to product promotion and manufacturer interactions with providers and patients. She also counsels extensively on product support programs, providing strategic guidance on program structures, program tactics and policies and procedures. Additionally, Ms. Dunn regularly represents life sciences companies in government enforcement actions and internal investigations involving a full range of fraud and abuse issues. She also conducts pre- and post-transaction reviews in connection with transactions in the life sciences industry and has advised clients on more than 100 life sciences-related transactional matters.

Ms. Dunn was recently named one of Lawdragon’s 500 Leading Litigators in America. She is active with Skadden’s diversity leadership initiatives and serves on the firm’s Women and Diversity committees. Ms. Dunn also was recently named to the Lawyers of Color’s inaugural list of Wonderful Women, which recognizes dynamic women attorneys working in law firms, companies and government agencies across the U.S. who show promise in their careers and demonstrate a strong commitment to advancing diversity in the legal profession. In addition, she previously was a fellow in the Leadership Council on Legal Diversity’s Fellows Program, a yearlong leadership and professional development initiative.

Representative clients include:

Enforcement and Investigations

• a specialty pharmaceutical company in the negotiation and implementation of a corporate integrity agreement involving price transparency and charitable donation controls
• the board of directors of a multinational life sciences company in connection with an assessment of the company’s compliance with health care compliance provisions of its deferred prosecution agreement
• a global pharmaceutical company in an investigation by the U.S. Department of Justice (DOJ) relating to product support activities
• a specialty pharmaceutical company in two separate investigations by the DOJ involving the U.S. Attorney’s Offices in Boston (District of Massachusetts) and Philadelphia (Eastern District of Pennsylvania) regarding the company’s sales and marketing practices and relationship with copay assistance charities
• a global pharmaceutical company in an investigation by the U.S. Attorney’s Office in New York (Southern District of New York) in connection with the company’s drug promotion strategy
• a specialty pharmaceutical company in criminal and civil investigations by the DOJ and more than 10 U.S. Attorney’s Offices and state attorneys general’s offices
• a medical device company in enforcement proceedings by the DOJ and FDA in negotiating a consent decree relating to manufacturing issues at the company’s plants

Regulatory Advice and Strategy

• multiple pharmaceutical companies in connection with providing strategic regulatory advice for reimbursement support activities
• a global pharmaceutical company in providing strategic guidance regarding its evaluation of alternative sites of care in response to the evolving care delivery landscape as a result of the COVID-19 pandemic
• a privately held pharmaceutical company in providing strategic guidance to executive-level management regarding the company’s health care compliance program, controls and policies
• a global biotech company in a congressional investigation into the company’s drug pricing strategy
• a group purchasing organization in connection with the submission and receipt of a favorable Department of Health and Human Services Office of the Inspector General advisory opinion
• an emerging specialty pharmaceutical company in submitting a citizen petition to the FDA
• a multinational food company in connection with the recall of millions of units of a nonalcoholic beverage caused by defective glass bottles
• various clients on the application of the federal Anti-Kickback Statute and False Claims Act to proposed business strategies

Transactions

• Biogen, Inc. in the spin-off of its Hemophilia business into a separate, publicly traded company called Bioverativ
• The Coca-Cola Company in its strategic partnership with Monster Beverage Corporation
• HealthSpring Inc. in connection with the federal and state regulatory aspects of its $3.8 billion acquisition by CIGNA Corporation
• Livongo in its $18.5 billion acquisition by Teladoc Health
• Miraca Holdings, Inc. in the acquisition of its subsidiary Miraca Life Sciences, Inc. by Avista Capital Holdings, L.P.
• OceanSound Partners in its acquisition of Netrix, a provider of infrastructure and a substance abuse and medication management system
• a pharmaceutical company in its sale of a controlled substance manufacturing facility
• multiple biopharma SPAC acquisitions