Off-Label Marketing of Drugs and Medical Devices
June 28, 2007
Policing the marketing of drugs and devices was once primarily the preserve of the Food and Drug Administration (FDA), which focused on misleading labels and outright quackery. No longer. Nowadays, many federal investigations, worked jointly by the FDA, Department of Justice (DOJ) and Health and Human Services (HHS), are fueled by the enormous financial recoveries that can be won from manufacturers accused of illegally promoting FDA-approved drugs or devices, bearing an FDA-approved label, for uses not approved by the FDA ('off-label' uses).
The Globalization of Investigations
June 26, 2007
For clients whose primary presence is in the United States, including e-commerce businesses, cross-border cooperation among law-enforcement organizations raises distinct and difficult issues. An effective defense requires knowledge of treaties and criminal law in two or more jurisdictions and collaboration among defense counsel in different countries.
In the Courts
May 30, 2007
Recent rulings of interest to you and your practice.
Can Money Laundering 'Travel with the Business'?
May 30, 2007
It can often be difficult for a white-collar attorney, who may have at least a passing familiarity with money laundering, to explain to a corporate attorney colleague how federal money laundering laws can impact deals on which the corporate attorney is advising clients. This article provides an example that may help you explain to your corporate law colleagues the impact that the federal money laundering laws could have on their work.
Whither the Guidelines?
May 30, 2007
You might be forgiven for concluding that the U.S. Sentencing Guidelines were largely a thing of the past following the Supreme Court's decision two years ago in United States v. Booker, 543 U.S. 220 (2005). The Court held that the Guidelines were purely advisory ' not mandatory ' and just one among many factors to be consulted in meting out a sentence under 18 U.S.C. ' 3553(a). Other factors specified in ' 3553(a) include such…
The Globalization of Investigations
May 30, 2007
Over the past several years, the Department of Justice ('DOJ') has expanded its tools and efforts to gather evidence from abroad and reciprocate by helping foreign prosecutors gather evidence in the United States. For a client whose primary presence is in this country, cross-border cooperation among law enforcement organizations raises distinct and difficult issues. An effective defense requires knowledge of treaties and criminal law in two or more jurisdictions, and collaboration among defense counsel in different countries.
Whistleblowing with a French Twist
April 30, 2007
A long accepted and familiar concept in Anglo-Saxon countries, whistleblowing, for cultural and historical reasons, has proven to be a rather unwelcome legal obligation. France's total opposition to whistleblowing has softened over time and has been accompanied by a greater understanding and appreciation of its implications. Nevertheless, strong pervasive principles of French law continue to govern this domain.
