As promised, I wanted to address some of the nuts and bolts of a due diligence review of a third party agent.  The focus of this due diligence inquiry is “reasonable inquiries” to identify potential risks of bribery by a third party.  Of course, the specific aspects of the inquiry will change depending on the particular facts surrounding the third party, the presence of red...

As promised, I wanted to address some of the nuts and bolts of a due diligence review of a third party agent.  The focus of this due diligence inquiry is “reasonable inquiries” to identify potential risks of bribery by a third party.  Of course, the specific aspects of the inquiry will change depending on the particular facts surrounding the third party, the presence of red...

If you look through the internet sites on the FCPA, you see numerous advertisements of companies offering due diligence reports — all of which may be needed for third party agents, joint venture partners, and mergers and acquisitions.  Due diligence has turned into a cottage industry.  The growth of such services reflects the greater demand by companies seeking to avoid FCPA liability. But lets start...

 Chairman Sensenbrenner Well, the message was clear yesterday to DOJ — the House intends to “update” the FCPA statute.  Crime Subcommittee Chairman Sensenbrenner made it clear a bill is coming, and it is likely the bill will pass the House.  What happens after that?  Who knows. The FCPA’s history has been cyclical in terms of Congressional oversight and modification.  When business interests coalesce, Congress...

In a November 2009 speech, Assistant Attorney General for the Criminal Division Lanny Breuer outlined an aggressive FCPA enforcement agenda targeting pharmaceutical and medical device companies. He noted that the depth of government involvement in foreign health systems, combined with fierce industry competition and an economic climate in which companies are tempted to invest fewer resources in compliance efforts, poses a significant risk of corruption....

As recently reported, the Senate Finance Committee has issued a report and requested HHS OIG to investigate the increased use of physician-owned distribution companies in the medical device industry, and whether PODs violate the federal anti-kickback statutes. The federal health care anti-kickback statute (“Anti-Kickback statute”) is a criminal statute that prohibits, among other things, giving or receiving any financial benefit or “remuneration” in exchange for,...

The Senate Finance Committee issued a letter to the HHS Office of Inspector General (OIG) requesting that the OIG investigate the growth of physician owned distribution companies (“PODs”) to distribute medical devices. The Senate Finance Committee’s inquiry is in response to the proliferation of PODs and the possible violation of fraud and abuse laws. A POD is an arrangement under which physicians invest and own...

The Senate Finance Committee issued a letter to the HHS Office of Inspector General (OIG) requesting that the OIG investigate the growth of physician owned distribution companies (“PODs”) to distribute medical devices. The Senate Finance Committee’s inquiry is in response to the proliferation of PODs and the possible violation of fraud and abuse laws. A POD is an arrangement under which physicians invest and own...

In keeping with my Russian heritage, I wanted to dedicate this blog entry to my Russian roots.  Not that anyone in my family was corrupt. Russia is the new China – economic opportunities abound and companies are rushing to enter into the Russian market. And for good reason. Income in Russia is expected to increase by 60 percent in the next four years Russia has great...

In a telephone conference call sponsored by the ABA, Lorin Reisner, Deputy Director of Enforcement at the SEC, disclosed that the SEC is relying on data analytics and industry-specific risk analysis to initiate FCPA investigations.  Reisner’s disclosure is extremely significant because he specifically explained that investigations initiated as a result of voluntary disclosures by companies constitute a smaller percentage of the SEC’s investigations. What does...