Avia Dunn’s practice focuses on internal and congressional investigations, health care regulatory enforcement actions, and complex civil and criminal litigation.

Bio

Ms. Dunn frequently counsels food, pharmaceutical and medical device clients on Food and Drug Administration (FDA) regulatory strategy, corporate compliance programs, GMP/QSR compliance, 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 food and life sciences industries.

Representative clients include:

  • 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 global pharmaceutical company in connection with a False Claims Act (FCA) suit pursued by a qui tam relator;
  • 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 biopharmaceutical company in advising senior management on the development and implementation of a comprehensive corporate compliance program;
  • 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;
  • 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;
  • various clients on the application of the federal Anti-Kickback Statute and FCA to proposed business strategies; and
  • due diligence counseling on numerous dealings, including an international beverage company in its 16.7 percent investment in and strategic partnership with an energy company and biotech spin-off of a hemophilia business.

Ms. Dunn also is active 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.

Credentials

Education

  • J.D., University of Pennsylvania Law School, 2008
  • M.B.A., Florida A&M University, 2004
  • B.S., Florida A&M University, 2004

Admissions

  • District of Columbia
  • Georgia
  • U.S. District Court for the Northern District of Georgia

Experience

  • Law Clerk, Hon. Marvin J. Garbis, U.S. District Court for the District of Maryland (2009-2010)