Avia M. Dunn

Ms. Dunn frequently counsels pharmaceutical and medical device clients on Food and Drug Administration (FDA) regulatory strategy, corporate compliance programs, product promotion, product recalls and litigation defense strategies in response to actions involving federal and state fraud and abuse laws. In addition, Ms. Dunn conducts pre- and post-transaction reviews in connection with transactions in the life sciences industry. She also has counseled companies in connection with the negotiation and implementation of Corporate Integrity Agreements (CIA), and regularly advises clients on compliance programs and issues relating to product support activities and specialty pharmacy relationships.

Representative clients include:

Government Inquires and Enforcement Actions

• a life sciences company in securing the dismissal of claims brought by a qui tam relator under the federal False Claims Act and the California and North Carolina state analogues;
• a specialty pharmaceutical company in two separate investigations by the U.S. Department of Justice 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 ongoing criminal and civil investigations by the Department of Justice and more than 10 U.S. attorney’s offices and state attorneys general offices;
• a specialty pharmaceutical company in the negotiation and implementation of a CIA involving price transparency and charitable donation controls;
• a medical device company in enforcement proceedings by the Department of Justice and FDA in negotiating a consent decree relating to manufacturing issues at the company’s plants;
• a pharmaceutical company as plaintiff in filing a federal action against the FDA to reverse its decision to delay approval of their new drug based on marketing exclusivity given to an earlier-approved competing drug;

Regulatory Advice and Strategy

• 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 biopharmaceutical company in matters involving reimbursement support and specialty pharmacy relationships;
• a biopharmaceutical company in providing strategic guidance regarding its patient support and promotional practices;
• a global biotech company in a congressional investigation into the company’s drug pricing strategy;
• a group purchasing organization in connection with an advisory opinion request from the Office of Inspector General;
• 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; and
• multiple biopharma SPAC acquisitions.

Ms. Dunn also is active with the firm’s diversity leadership initiatives and serves on Skadden’s women and family diversity committees. In addition, Ms. Dunn has represented pro bono clients in domestic violence proceedings.