Over the past two years, the US Department of Justice (DOJ) and Securities and Exchange Commission (SEC) have begun actively using the Foreign Corrupt Practices Act (FCPA) to target U.S. medical device companies’ overseas marketing and business practices. In fact, during the 30 years following the passage of the FCPA in 1977, the SEC only brought 15 cases against medical device companies under the Act, but in the last year has already prosecuted 12 FCPA cases against device companies. Now, the SEC is investigating major medical device firms for possible FCPA violations. Thus, the message to the U.S. medical device industry is clear: take steps to effectively manage all monetary aspects of your marketing and distribution efforts in foreign countries to avoid being caught up in an FCPA enforcement action.

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James R. Ravitz
ravitz.james@arentfox.com
202.857.8903

Alana Wexler
wexler.alana@arentfox.com
202.828.3463