Avia Dunn provides strategic, solutions-oriented counsel to FDA-regulated companies on complex government investigations, regulatory enforcement matters, compliance program design and oversight, and high-stakes transactions.
Dunn has substantial experience handling the various challenges faced by FDA-regulated companies, including compliance with federal and state fraud and abuse laws, FDA regulatory enforcement matters and HIPAA privacy restrictions. Additionally, she counsels life sciences companies on matters related to the development, implementation and oversight of their health care compliance programs, both proactively and in connection with the negotiation of corporate integrity agreements. She has also served as a subject-matter adviser on more than 150 life sciences-related transactional matters. Ms. Dunn relies on these varied experiences to assess over-the-horizon risk and offer personalized solutions to clients.
Lawdragon Honors
| Honor | Year | Practice |
|---|---|---|
| The 2026 Lawdragon 500 Leading Global Investigations Lawyers | 2026 | Life Sciences & Healthcare Investigations, FDA Regulatory, Enforcement |
| The 2026 Lawdragon 500 Leading Litigators in America | 2026 | Complex Civil & Criminal Litigation, esp. Health, Pharmaceuticals |
| The 2025 Lawdragon 500 Leading Litigators in America | 2025 | Complex Civil & Criminal Litigation, esp. Health, Pharmaceuticals |
| The 2024 Lawdragon 500 Leading Litigators in America | 2024 | Complex Civil & Criminal Litigation, esp. Health, Pharmaceuticals |
| Lawdragon 500 Leading Litigators in America | 2022 | Complex Civil & Criminal Litigation, esp. Health, Pharmaceuticals |
Litigation, Enforcement and Investigations
- Miraca Holdings in securing the dismissal of claims brought by a qui tam relator under the federal False Claims Act and California and North Carolina state analogues
- a pharmaceutical company in successfully persuading the DOJ to close its investigation of certain product support activities with no enforcement action. The relators voluntarily dismissed the underlying qui tam action brought under the False Claims Act after the government declined to intervene
- a major medical system in connection with a voluntary self-disclosure regarding financial relationships with secondary care facilities
- 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
Regulatory Advice and Strategy
- a group purchasing organization in connection with the submission and receipt of a favorable U.S. Department of Health and Human Services Office of the Inspector General advisory opinion
- an emerging specialty pharmaceutical company in submitting a citizen petition to FDA
- a multinational food company in connection with a product recall
- an importer in connection with a hand sanitizer recall
Transactions
- Mars, Incorporated in its $35.9 billion acquisition of Kellanova
- Waldencast Acquisition Corp. in connection with its business combination transaction with Obagi Cosmeceuticals and Milk Makeup
- Peet’s Coffee & Tea, Inc. in its acquisition of a majority stake in Intelligentsia Coffee & Tea, Inc.
- Krispy Kreme Doughnut Corporation in its acquisition of a majority stake in Insomnia Cookies LLC
- Mayne Pharma Group Limited in its $475 million sale of Metrics Contracts Services to Catalent, Inc.
- The Coca-Cola Company in its strategic partnership with Monster Beverage Corporation
- Livongo in its $18.5 billion acquisition by Teladoc Health
- OceanSound Partners in its acquisition of Netrix, a provider of cloud infrastructure and a substance abuse and medication management system