David J. Ludlow

DAVID LUDLOW is a partner in the Washington, D.C. office of Sidley Austin. He concentrates his practice on representing life science and other corporations in white collar matters, including internal investigations, government enforcement actions, and litigation. These investigations and related enforcement actions/litigation involve a range of issues, including marketing practices, clinical trials, product diversion, pricing and reimbursement, good manufacturing practices, False Claims Act/qui tam litigation, the federal Anti-Kickback Statute, and the Foreign Corrupt Practice Act (FCPA).

David has significant experience conducting internal investigations in both the U.S. and abroad and advising U.S. and non-U.S. companies in international enforcement matters, including FCPA investigations, and has represented clients in various enforcement matters and investigations before the U.S. Department of Justice, U.S. House of Representatives, the Food and Drug Administration, Health and Human Services Office of Inspector General, and U.S. Securities & Exchange Commission.

His practice includes counseling corporations about their corporate compliance programs and conducting program reviews, risk assessments, employee training, M&A and contractor due diligence, and policy/procedure development.

Recent Representative Engagements Include:

Successfully obtaining DOJ declinations for two multinational companies in significant FCPA investigations involving conduct in numerous countries around the world.
Successfully obtaining a DOJ declination to intervene for a major pharmaceutical company in a qui tam matter related to clinical trial practices (N.D. Ill.).
Successfully obtaining a DOJ declination to intervene for a major pharmaceutical company in a qui tam matter related to pricing and reimbursement (E.D.P.A).
Representing a major pharmaceutical company in an ongoing DOJ and FDA investigation under the Food, Drug, and Cosmetic Act.
Representing a major pharmaceutical company in an ongoing qui tam matter related to state Medicaid claims (D. Mass).
Representing a major pharmaceutical company in DOJ and State AG investigations involving off-label promotion and kickbacks.
Representing a major pharmaceutical company in an ongoing DOJ FCPA investigation.
Representing major pharmaceutical and other companies in numerous internal FCPA investigations, involving countries in Eastern Europe, Asia, the Middle East, and Latin America (e.g., Argentina, Brazil, Belarus, Belgium, Bulgaria, China, Georgia, Germany, Greece, Iran, Libya, Malaysia, Poland, Russia, Saudi Arabia, Turkey, Ukraine, Venezuela).
Representing major pharmaceutical and life sciences companies in separate DOJ product diversion/fraud investigations.
Representing a major pharmaceutical company in Oil-for-Food, OFAC, and anti-boycott investigations.
Successfully representing an individual defendant in a criminal bribery prosecution (D.D.C. Case No. 1:06-cr-00249).

Good to know

Areas of Practice 1) Food, 2) Drug and Medical Device Compliance and Enforcement, 3) Securities & Derivatives Enforcement and Regulatory and 4) White Collar: Government Litigation & Investigations
Law School Brigham Young University - J. Reuben Clark Law School, J.D., 2003
Education Brigham Young University, B.A., 1999
Bar Member / Association District of Columbia Bar Association, New York State Bar Association
Most recent firm Sidley Austin LLP
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