Category: Uncategorized

The Real Implications of the Glaxo Enforcement Action in China

The headlines get worse and worse.  More companies under investigation.  More individuals detained and under investigation.  The shockwave in the pharmaceutical and medical device industries is palpable.  It is all understandable.  The message from the Chinese is two-fold – they are going to enforce China’s bribery laws, especially in those markets that have a direct and immediate nexus to China’s consumers. We all have heard...

Instilling Ethics in a Compliance Program

I continue to be astounded by one simple fact (candidly there are others) – companies do not understand that creating and maintaining an ethical culture improves bottom-line financial performance.  A commitment to ethics as an enhancement to an existing compliance program not only improves performance of the compliance program, but improves corporate profitability and long-term shareholder value. From my days as a history major, I...

Internal Investigations in a “Bet the Company” Case

Lawyers like to be dramatic.  Litigators love to be dramatic.  When it comes to a “bet the company” scandal, the company’s survival will depend not only on the quality of an internal investigation, but the company’s broader “crisis management” skills. There is no question when the stakes are high; an internal investigation must be conducted in a professional and careful manner so that it can...

The Heart of AML Compliance: Sanctions Violations

The increase in AML enforcement has focused on sanctions violations.  The problem continues to plague financial businesses which have yet to adapt to the United States’ ability to enforce US sanctions laws and regulations against conduct which occurs outside the United States.  Short-sighted compliance programs fail to integrate a global perspective on compliance. Standard Chartered was forced to pay fines and penalties for stripping Iranian...

Corporate Risks: What Do Corporate Leaders Worry About?

This column may be another example of what I call — “ A profound grasp of the obvious.”  The answer to the question of this column is easy according to everyone – financial performance, quarterly results and shareholder value.    So is that all on the mind of corporate leaders? We all know the problems created by executive compensation schemes and the short-sighted management perspective that...

Drilling Down on Due Diligence: Raising the Bar

I am sure Justice Department and Securities and Exchange Commission lawyers sometimes sit back and marvel at the world they have helped create – Companies are devoting more resources to the due diligence process for screening third parties.  Companies are building due diligence screening procedures and more sophisticated protocols to minimize risk.  The message has come through loud and clear – conduct due diligence and...

Einstein’s Theory of Relativity and Compliance

I am always surprised at creative links between compliance principles and major historical events and concepts.  Tom Fox, my colleague, is particularly adept at drawing these connections, especially in his recent series describing the link between the Gettysburg battles and specific compliance topics. In his shadow, I would offer another such analogy.  Einstein’s theory of relativity has a direct application to compliance, or at least a...

Ten Required Steps To Ensure Effective Compliance Programs by Pharmaceutical and Medical Device Companies (Part III of III)

In response to the Glaxo controversy and the continuing risks of aggressive FCPA enforcement, drug and device companies need to review and enhance their anti-corruption compliance programs.  No hemming and hawing – this is a must for every company involved in these industries.  To ignore the current situation, is to do more than just put a head in the sand – you might as well bury...

Pharmaceutical and Medical Device Companies: Taking it on the Chin (Part II of III)

As the Glaxo controversy unravels each day, it is important to remember the enforcement context in which the current prosecution in China is occurring.  The Glaxo case will go down in FCPA enforcement history as the equivalent of the Siemens and Wal-Mart case — it represents a new, and risky trend in anti-corruption enforcement: China is now entering the arena with its enforcement muscle.  For...

Bad News for the Drug and Device Industries: Glaxo’s Systemic Breakdown in China (Part I of III)

Mark Twain, one of my favorite authors, always said it best – “Do the right thing. It will gratify some people and astonish the rest.” For drug and device companies, Mark Twain’s observation is becoming the industry standard.  Since 2009, the drug and device industry has been the proverbial punching bag for FCPA enforcement.  While the overall numbers are less than the major FCPA cases...