Thoughtful Insight and Updates on Legal Issues that Matter to You

Perspectives

U.S. Indicts Three Credit Suisse Bankers

Last Thursday, Federal prosecutors filed charges against Markus Walder, Susanne D. Rüegg Meier, Andrea Bachmann, and Josef Dörig for conspiring with other Swiss bankers to defraud the United States. The superseding indictment implicates the three Credit Suisse bankers and Swiss trust founder along with four other defendants who were charged February 23, 2011. Although the indictment refers to an “International Bank” and not Credit Suisse, details of the information point directly to the Swiss banking giant. The new charges mount pressure on offshore bankers and taxpayers alike as the U.S. toughens its stance on foreign banks that help Americans evade their taxes.

Mistrial Declared in Foreign Corrupt Practices Act Case After Jury Could Not Reach Verdict

On Thursday, July 7, 2011, U.S. District Judge Richard Leon of the District of Columbia declared a mistrial in a criminal foreign bribery case under the Foreign Corrupt Practices Act (“FCPA”) involvingallegations of a corrupt deal to sell $15 million in supplies to Gabon’s Ministry of National Defense. Prosecutors from the Department of Justice alleged that defendants John Wier III, Pankesh Patel, Lee Allen Tolleson and Andrew Bigelow tried to bribe Gabonese officials to win contracts.

World-Check Comments On Money Laundering Risk Presented By Venezuela

As Venezuela continues to destabilize, anti-money laundering and Bank Secrecy Act compliance officers must take notice of the increased risks associated with doing business with corporations and banks located in the there. A destabilized Venezuela could result in a litany of AML and regulatory compliance issues ranging from money laundering to Iranian and Cuban Sanctions programs violations.

FinCEN Releases Final Rule Clarifying Money Services Businesses Definitions, Includes Foreign-located MSBs Doing Business in U.S.

On July 18, 2011, the Financial Crimes Enforcement Network of the United States Department of the Treasury (“FinCEN”) issued a final rule amending the Bank Secrecy Act (BSA) implementing regulations regarding Money Services Businesses (“MSBs”). The rule clarifies which businesses qualify as MSBs and are thus subject to the anti-money laundering regulations of the BSA. A copy of FinCEN’s press release can be read here.

Democratic Senator Challenges Tax Shelters and Offshore Havens

Senator Carl Levin (D-Mich) unveiled legislation last week that seeks to limit offshore tax loopholes and strengthen American enforcement capabilities. The senator has introduced similar measures in the past, but is hopeful that Washington’s current focus on the deficit will carry his latest proposal “over the goal line.”

FDA Issues Draft Guidance for New In Vitro and Radiology 510(k) Exemptions

On July 12, 2011, the FDA issued a draft guidance which outlines FDA’s enforcement policy regarding certain Class II medical devices and 510(k) premarket notification requirements. The draft guidance was issued in anticipation of a rule reclassifying certain in vitro and radiology Class II devices as Class I. A complete list of the devices can be found in the draft guidance. The reclassification of devices is one component of the agency’s plan to overhaul the system for reviewing and clearing medical devices. Please see our previous report on the FDA’s plan here and the FDAs draft guidance on in vitro companion diagnostic devices here.

FSMA Checklist: Dietary Supplement Guidance and Anti-Smuggling Strategy

Pursuant to the Food Safety and Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) is required to meet various deadlines for the implementation of new food safety systems. July 3, 2011 marked 180 days since President Obama signed the FSMA into law as well as the deadline for completing the new dietary supplement ingredient guidance and an anti-smuggling strategy. On July 5th the FDA announced it had completed two tasks required by the FSMA.

Patient Receives First Fully Synthetic Organ Transplant

Last month, a 36 year-old cancer patient received the world’s first trachea implant made of his own stem cells grown on a man-made plastic matrix. Researchers from Sweden, England and the U.S. collaborated in Stockholm to create the trachea from scratch in 48 hours.

FDA Proposes Guidance Document for In Vitro Companion Diagnostic Devices

Last week, the U.S. Food and Drug Administration (FDA) announced the release of a guidance document for in vitro companion diagnostic devices. According to the FDA, companion diagnostics are “tests used to help health care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give.”

Organic Labeling of Cosmetics under Scrutiny in California

The Center for Environmental Health (CEH), a public advocacy group in California, filed suit in the Superior Court of the State of California on June 16, 2011, against 26 cosmetic companies alleging companies sold their products with the aid of misleading organic product labels. CEH, seeking injunctive relief, wants to encourage cosmetic companies to use organic ingredients and ensure that consumers can trust organic labels.