Medical Device Link.

REGULATORY OUTLOOK

Return to Article: Risk Areas for Overseas Sales and Marketing

Recent settlements under the FCPA include the following examples:

• Micrus Corp., a U.S. medical device company, settled a $450,000 FCPA claim in 2005 related to alleged payments of $105,000 to foreign physicians in a position to direct hospital purchases of Micrus’s embolic coils.
  
  
• In September 2007, Immucor, a U.S.-based manufacturer of blood transfusion instruments, and its CEO settled SEC charges involving bribery allegations in Italy. To resolve the allegations, the company agreed to enter into a cease-and-desist order with the SEC, and the CEO agreed to pay a civil penalty of $30,000. Separately, a federal judge approved a $2.5 million shareholder action against Immucor in connection with the bribery allegations.
  
  
• In September 2007, the SEC filed charges against Monty Fu, a U.S. resident and former chairman and CEO of Syncor International Corp. The charges related to improper payments made between 1985 and 2002 by Syncor’s subsidiary in Taiwan (Syncor Taiwan) to physicians employed by state-owned or state-controlled hospitals. Fu subsequently consented to an order requiring him to pay a $75,000 civil penalty. Previously, in December 2002, Syncor Taiwan settled a Department of Justice enforcement action concerning the improper payments by paying a $2 million criminal fine. Its parent company settled an SEC enforcement action concerning the improper payments made by Syncor Taiwan and certain other foreign subsidiaries by paying a $500,000 civil penalty.